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Registration and Grouping of
24 and 25 November 2011
Medical Device BranchHealth Products Regulation Group
1
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Scope
Recap on Product Registration Dental
Devices
Grouping Rules for Dental Products
Case Studies
Special Considerations
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Rationale for Regulating Health Products
devices available in Singapore are:
SAFE
EFFECTIVE (perform according to intended purpose)
APPROPRIATELY USED
Absolute safety cannot be guaranteed
Mission:To be the LEADING INNOVATIVE AUTHORITY
protecting and advancing NATIONAL HEALTH and
SAFETY
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Developing the Regulatory Framework
Ease of accessto all devices
Public healthAl ignment of
regulatory
ramewor s
ResourceAf fordabi li ty
Transparencyand
Risk-based a roach for a least burdensome re ulator framework that adds value
predicability
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Medical Device Branch
- To safeguard public health and safety by implementing regulatory
controls through a programme of pre-market assessment of devices,
manufacturing controls and post-market vigilance
- To ensure medical devices available in Singapore are of an acceptable
standard in accordance to the Health Products Act and Health Products
Total No. of Approved Medical Devices onKey
Statistics
the Singapore Medical Device Register
(as of 30 Sept 2011)
7,932
No. of listin received Year 2010/11 3,659
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No. of listing approved (Year 2010/11) 1,518
Developing the Regulatory Framework
- -
- - - , ,
market)
Built on the strengths of model regulatory agencies - US FDA, Health
ana a, uropean n on sys em an us ra a .
These 5 are the founding members of the Global Harmonisation Task
Force (GHTF).
GHTF Guidance documents used as reference.
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, , ,
presentation and advertisement of health products
and of active ingredients used in the manufacture
Part II Administration of the Act
Part III Manufacture & Import of Health ProductsProducts , , .Part VIII]
Part IV Supply of Health Products
Act our
Part VI Licences
Part VII Registration of Health Products
Authority
Prosecution
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PRODUCT REGISTRATION
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Implementation Timeline
Phase 3B: FULL
IMPLEMENTATION
Mandatory PRODUCTRe istration of Class A & B
ea t
Products Act
Phase 3A:
-
C&D
- Mandatory licensing of Dealers
5-year
Voluntary
Product
Phase 2:Accept Product Registration and Licence applications
Phase 1: Post-market Duties (e.g. keep supply records, report adverse
events and FSCAs)
Registration
(VPR)
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1 Jan 20121 Nov 2008 10 Aug 20101 Nov 2007
Dental Devices: Risk Classif ication
E.g: Bone matrix implants,
dental x-ray systems
Class B:
.g.: urs, crowns, a u men s,
scaling systems
Class A:
. ,
impression materials
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HSAGuidanceGN13:Guidanceonriskclassificationofgeneralmedicaldevices
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Class A and B Devices
(i) Registered Devices:
Listed on the Singapore Medical Device Register (SMDR)
Can be imported and supplied in Singapore
ev ces on e rans on s :
Submitted (by 30 November 2011) but under processing
Can be imported and supplied in Singapore
(iii) Devices supplied through Special Authorisation
(iv) Devices that do not fulfill (i) or (ii) above:
Prohibited from import and supply in Singapore from 1 Jan 2012
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Class C and D Devices
(i) Registered Devices:
Listed on the Sin a ore Medical Device Re ister SMDR
Can be imported and supplied in Singapore
(ii) Devices on the Transition List:
Submitted (by 30 April 2010) but under processing
Criteria apply
Can be imported and supplied in Singapore
(iii) Devices supplied through Special Authorisation
(iv) Devices that do not fulfill (i) or (ii) above:
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Prohibited from import and supply in Singapore
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Pro-Enterprise Steps
1. 5 year period (2002-2007) No fees for
2. Exemption for most Class A devices 6,000items exempted
(Class A constitutes 60% of Singapores total
low risk MD market)
. - Industry has time to adjust to a regulatedenvironment
4. Incentive Fee (reduced by 20%)
5.Grouping of devices for registration 1
6. Abridged evaluation of devices resulting inlower registration cost & faster market entry
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Reaching Out to Our Stakeholders
Conducted 60 free-of-char e
industry training and briefing
sessions (2009 2011)
Availabi li ty of PublicInformation:
. . .
Frequently Asked
Questions (FAQ) Section
Quick Guide
MEDICS Application
Guides
Published Industry Briefing
slides
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PRODUCT REGISTRATION
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Product RegistrationSTART
No need to register
Yes
medical device?
device.
Comply with all other
No
Do I need to register my
may apply.
Yes
Grouping of medical
devices completed?
Register the medical
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device
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What is a medical device?
Qn: What is a medical device?
, , , ,appliance, implant, in vitro reagent or calibrator, software, material or other
similar or related article that is intended by its manufacturer to be used, whetheralone or in combination, for humans for one or more of the specific purposes of
(a) diagnosis, prevention, monitoring, treatment or alleviation of any disease;
(b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
(c) investigation, replacement, modification, or support of the anatomy or of a physiological process;
(d) supporting or sustaining life;
(e) control of conception;
(f) disinfection of medical devices; or
(g) providing information for medical or diagnostic purposes by means of in vitro examination of
specimens derived from the human body, and which does not achieve its primary intended action in
or on the human body by pharmacological, immunological or metabolic means, but which may be
assisted in its intended function by such means.
Definition is from the First Schedule of HealthProducts Act 2007 (Act)
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Dental Products that are not
me ca ev ces
Examples of dental products that are not medical devices
i. Teeth whitening products (no medical claims)
.
iii. Machining or polishing equipment for fabricating/customising dentalproducts in dental labs
v. esearc -use on y pro uc s
v. Teaching aids
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Products for Research Use
-
only
-
only
investigation
investigationIntended and labeled bythe Product Owner for
A device suppl ied for a
bench/animal testing.
NOT for use on humans.
investigation on humanbeings.
Exempted from registration.
device.
pp y or mpor permusing CTM (MD) form (HSA
Clinical Trial Branch)
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Product RegistrationSTART
No need to register
Yes
medical device?
device.
Comply with all other
No
Do I need to register
may apply.
Yes
Grouping of medical
devices completed?
Register the medical
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device
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Must all medical devices be
registered?
: ust a me ca ev ces e reg stere
No. The following medical devices shall not require registration:. ustom-ma e me ca ev ces
ii. Class A device that is exempted from product registration (GN-22)
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Custom-made Vs Customised Medical Device
Custom-made Medical Device
No registration required
Ceramic
c ps u y
Teeth,
Crown,
Inla s
Factory
processing Modified by the
Professional
Customised Medical Device
registration required
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Exempted Dental Medical Devices
Important note
Only medical devices that are l isted in GN-22 (Guidance to the List of
Medical Devices Exempted from Product Registrat ion) shal l be,
GN-22.
1. Dental chairs
2. Dental amalgamator
3. Dental curin li ht
4. Dental lights
4. Dental handheld mirror
5. Orthodontic pliers6. Class A reusable dental surgical instruments
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Examples of Exempted Dental
Products
E.g:
dental extraction forceps
dental scalpels dental scissors
retractors (e.g. cheek retractors)
rubber dam instruments
crown removers
Im or tant note
Only reusable dental surgical instruments that satisfyALL of the fol lowing
conditions shall be eligible for exemption:
se so e y n e ora cav y
Class A Non-sterile
Non-active
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Examples of Dental Devices that
i Sul hide detection device class B
- intended to be used in vivo, to manually
measure periodontal pocket probing depths,detect the presence or absence of bleeding on
probing, and detect the presence of sulfides in
periodontal pockets, as an adjunct in the
diagnosis of periodontal diseases in adult
.
(i i) Root apex locator (class B)
- intended for locating the apex of the tooth
and measuring the length of the root canal.
(i ii) Dental autoclave (class C)- Intended for sterilising dental instruments prior to
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.
Product RegistrationSTART
No need to register
Yes
medical device?
device.
Comply with all other
No
Do I need to register my
may apply.
Yes
Grouping of medical
devices completed?
Register the medical
Yes
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device
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Grouping Process
Who should perform grouping of the medical devices?
The registrant (verify with Product Owner)
When should rou in be erformed? Before submission of product registration application
What are the advanta es of rou in ? Cost savings for the industry
Reduce number of registration applications
Reduce product registration fees
, . .
Where can I find the rules to group medical devices? -
registration
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EXISTING GROUPING RULES
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Types of grouping: GN-12 Guidance
Medical Device
General Medical
In Vitro Diagnostic (IVD) Device
SINGLE
FAMILY SYSTEM
SYSTEM GROUP
GROUP IVD TEST KIT
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IVD CLUSTER
Types of grouping: GN-12 Guidance
Medical Device
General Medical In Vitro Diagnostic (IVD) Device
FAMILY SYSTEM
SYSTEM GROUP
GROUP IVD TEST KIT
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IVD CLUSTER
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Case Study 1 Existing Rules
Dental Impression Materials
A material designed to reproduce the structure of a patients teeth and gums, or other oral
anatomy, after being placed on an impression tray and inserted into the mouth. This is a
single-use device.
Productname MainconstituentXYZ Impresso dental impression Alginate
XYZ FastSet dental im ression Pol vin l Siloxane
XYZ SuperSet dental impression Polyether
EXISTING RULES:
3 separate applications required
Different impression material
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Types of grouping: GN-12 Guidance
Medical Device
General Medical In Vitro Diagnostic (IVD) Device
FAMILY SYSTEM
SYSTEM GROUP
applications
GROUP IVD TEST KIT
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IVD CLUSTER
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Continuous
- .
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Types of grouping: GN-12 Guidance
Medical Device
General Medical In Vitro Diagnostic (IVD) Device
FAMILY SYSTEM
Dental
Grouping
SYSTEM GROUPu es:
class A and B
GROUP IVD TEST KIT
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IVD CLUSTER
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Alternative Dental Grouping Rules
Class A and B Dental Devices Only
Class C and D Dental Devices
Standalone software
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Grouping for Dental Devices
Dental Devices
Class A or B
D
AlternativeGrou in rules for
Grouping as per Grouping as per
Dental Devices- -
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Dental Grouping Terms (DGT)74 Dental Terms Available:
(Find the relevant description)No. Terms
1 Adhesive kit for dental composite
2 Cryoanaesthesia device, dental
3 Cryogenic spray, dental
No. Terms
21 Dental implant, accessories
22 Dental implant, prosthetic teeth bar
23 Dental implant, suprastructure
4 Cusps, dental
5 Dental abrasives
6 Dental adhesives/ primers
7 Dental burs
24 Denta l imp lant /prosthesis, surgical procedure k it
25 Dental impression materials
26 Dental precision attachments
27
Dental procedure console and accessories, hydraulic (for use
with handpieces)
8 Dental caries detector, electrical impedance
9 Dental car ies detecto r, op tical induced fluorescence
10 Dental caries removal solution
11 Dental casting materials
i i
28
Dental procedure console and accessories, line-powered (for use
with handpieces)
29
Dental procedure console and accessories, pneumatic (for use
with handpieces)
30 Dental procedure handpiece, hydrauli cl i i l
12 Dental cavity liner
13 Dental cement
14 Dental cement kit
15 Dental crowns/ bridges
31 Dental procedure handpiece, line-powered
32 Dental procedure handpiece, pneumatic
33 Dental pulp testing electrode gel
34 Dental pulp-capping material
l i i i
16 Dental dry field device
17 Dental dry field kit
18 Dental etching composite
19 Dental implant debridement brush
l i i i
36 Dental restorative / cavity varnish
37 Dental restorative materials
38 Dental restorative/ repair kit
39 Dental retention pin
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20 Dental implant extractor 40 Dental retention pin kit
Dental Grouping Terms (DGT)No. Terms
41 Dental scalers, ultrasonic
42 Dental scalers, rotary
No. Terms
58 Gingival retraction solution
i l i l i i l
43 Dental scalers, pneumatic
44 Dental solution, scaling
45 Dental scaling system, ultrasonic
- i l i l i , i l -
60 Oral wound dressing, non - animal/ microbial-derived
61 Orthodont ic appliance archwire-cooling device
46 Dental scaling system, rotary
47 Dental scaling system, pneumatic
48 Dental sealants, endodontic
62 Or thodon tic app liance force -measur ing gauge
63 Orthodontic appliances
64
Orthodontic space maintainer (for prematurely lost
deciduous teeth)
49 Dental sealants, pit/fissure
50 Dental shaded pontic kit
51 Denture clasps
65 Palatal impression kit
66 Periodontal dressing, non -animal/ microbia l- derived
67 Root canal fi lli ng-removal solution
52 Denture reliners
53 Facebow
54 Fix ture/app liance dental dr il l, sing le-use
68 Root canal i rr igat ion/ r insing solution
69 Root canal obturation kit
70 Root canal post kit
71 Root canal posts
55 Gingiva bleaching protector
56 Ging ival retraction cord, non-medicated
57 Gingival retraction kit
72 Root surface conditioner
73 Tooth preservation kit
74 Warm-bonded endodont ic ob tu rat ion system
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Refer to Annex 2 for detailed list of DGT and their descript ions
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Dental Grouping Rule
Each Dental member:
re ass non-exemp e or c ass ev ce
Yes
Falls within the description of 1 Dental Grouping Term (DGT)
Yes
Are of the same risk class
Yes
Are from the same product owner
Yes
One application under the Dental Grouping Term
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,
are intended to be used together with the dental device.
Finding the Dental Grouping Term
Obtain the list of DGT and
Find a relevant DGTdescription
Not available
Available
description
Follow GN-12 grouping rules
Submit as 1 applicationusin the DGT
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Case Study 1Dental Impression Materials
,
anatomy, after being placed on an impression tray and inserted into the mouth. This is a
single-use device.
Product name Main constituentXYZ Impresso dental impression Alginate
XYZ FastSet dental impression Polyvinyl Siloxane
XYZ SuperSet dental impression Polyether
EXISTING RULE: ALTERNATIVE GROUPING:
3 separate FAMILY appl ications USING DGT
because:
Different impression material
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Case Study 1 Dental Grouping Rules
- Class A
DGT: Dental
a s w n e escr p on o en a roup ngTerm (DGT)
Impression material
Are of the same risk classAll members of DGT
are Class A
Are from the same product ownerSame Product Owner:
XYZ
One application under the Dental Grouping TermOne Class A application
: Dental Im ression
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material
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Case Study 1
Dental Impression Materials
A material designed to reproduce the structure of a patients teeth and gums, or other oral
anatomy, after being placed on an impression tray and inserted into the mouth. This is a
single-use device.Product name Main constituent
XYZ Impresso dental impression Alginate
XYZ FastSet dental impression Polyvinyl Siloxane
XYZ SuperSet dental impression Polyether
3 separate FAMILY appl icationsDental Grouping Rule:
because:
Different impression material
Dental Impression Material
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Case Study 2
Dental cements
Compounds used in dentistry/ orthodontics typically to bond a dental
rosthesis to the anatom lutin a ent , to form an insulatin la er under
dental restorations.
Productname DescriptionXYZ Im ressocement Main constituent: Zinc hos hate
Available as 2g and 4g syringesXYZ FastSet cement Main constituent: Polycarboxylate
Available as 2g syringe and 2g kit (dispenser,
etchant, adhesive, primer)
XYZ SuperSet cement Main constituent: Glass Ionomer
Available as 2g and 4g syringes
EXISTING RULE:
3 separate FAMILY appl ications
ALTERNATIVE GROUPING:
USING DGT
because:Different cement material
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Case Study 2 Dental Grouping Rules
Class BAre Class A (non-exempted) or class B device
DGT: Dental CementFalls within the description of 1 Dental GroupingTerm DGT
All members of DGT
are Class B
Same Product Owner:
XYZAre from the same product owner
One Class B application
: Dental Cement
One application under the Dental Grouping Term
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Case Study 2
Dental cements
Compounds used in dentistry/ orthodontics typically to bond a dental
rosthesis to the anatom lutin a ent , to form an insulatin la er under
dental restorations.
Productname DescriptionXYZ Im ressocement Main constituent: Zinc hos hate
Available as 2g and 4g syringesXYZ FastSet cement Main constituent: Polycarboxylate
Available as 2g syringe and 2g kit (dispenser,
etchant, adhesive, primer)
XYZ SuperSet cement Main constituent: Glass Ionomer
Available as 2g and 4g syringes
EXISTING RULE:
3 separate FAMILY appl icationsDental Grouping Rule:
because:Different cement material
1application using DGT
Dental Cement
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Case Study 3
Prosthodontic Tooth Restoration Procedure Kit
materials and dental products intended for use during a normal tooth
.
i. Resin tooth bonding agent
.
iii. Cavity varnish/primer
iv. Coatin material for resin fillin s
v. Tooth shade resin material
2 Device proprietary name on label:
-ABC Clinic Prosthodontic Tooth Restoration Procedure Kit
-XYZ Clinic Prosthodontic Tooth Restoration Procedure Kit
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Case Study 3Prosthodontic Tooth Restoration Procedure Kit
1. 4 syringes for tooth bonding purposes, consisting of the following:
1x s rin e with sin le li ht-cure resin com onent
1 x syringe with pre-filled self-cure resin adhesive
1x syringe with ethchant
1 x syringe with coupling agent
. ar es n ca or con a n yes n a g yco ase a s a n car ous en n
3. 1 x syringe with cavity liner
4. 1 x s rin e containin cavit rimer + 1 x s rin e containin cavit varnish
5. 1 x syringe containing Luminescence light-cured coloring resin (coating material for resin
fillings)
6. 1 x s rin e containin PermanentFlo Flowable com osite tooth shadin resin material
7. 1 x Tongue guard
8. 1 x Mouth prop
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Case Study 3
Prosthodontic Tooth Restoration Procedure Kit
2 Device proprietary name on label:
-ABC Clinic Prosthodontic Tooth Restoration Procedure Kit
-XYZ Clinic Prosthodontic Tooth Restoration Procedure Kit
EXISTING RULE:
2 separate GROUP applications
ALTERNATIVE GROUPING:
USING DGT
because:
Different GROUP proprietaryname
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Case Study 3 - Dental Grouping Rules
Are Class A (non-exempted) or class B device Class B
Falls within the description of 1 Dental GroupingTerm DGT
DGT: Dental Restorative
Materials
All members of DGT are
Class B. Contains Class
A accessories in Kit.
Are from the same product ownerProduct Owner: XYZ
One application under the Dental Grouping Term One Class B application: Dental RestorativeMaterials
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Case Study 3 - Dental Grouping Rules
Prosthodontic Tooth Restoration Procedure Kit
2 Device proprietary name on label:
-ABC Clinic Prosthodontic Tooth Restoration Procedure Kit
-XYZ Clinic Prosthodontic Tooth Restoration Procedure Kit
EXISTING RULE:
2 separate GROUP applications Dental Grouping Rule:
because:
Different GROUP proprietary
1 application using DGT
Dental Restorativename
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Dental Grouping rules?
Endosseous ImplantDescriptor:An endosseous dental implant is a device made of a material such as titanium
or an um a oy, a s n en e o e surgca y p ace n e one o e upper or ower aw
arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a
patient's chewing function.
XYZ ELEMENT Endosseous Implant indicated for for subgingival implantation only
i. Implants are of different sizes, shapes (cylindrical vs conical-cylindrical), diameters and
lengths
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Quiz 1: Qualif ies for New Dental
Dental Implants: Class C device
Follow existing
GN-12 rules
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LISTING ONTO THE
SINGAPORE MEDICAL DEVICE
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Listing Following New Dental Grouping
Case Study 1: Dental Impression Materials
A material designed to reproduce the structure of a patients teeth and gums, or other oral
anatomy, after being placed on an impression tray and inserted into the mouth. This is asin le-use device.
Productname MainconstituentXYZ Impresso dental Alginate
1application using DGT
impression
XYZ FastSet dental
impression
Polyvinyl Siloxane
uper e en a
impression
o ye er
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Listing Following New Dental Grouping
Case Study 1: Dental Impression Materials List ing on SMDR
XYZ Dental Impression Materials
It is designed to reproduce the structure of a patient's teeth and gums, or other oral anatomy,
Dental
Class A medical device
NFY-DEV-000123-11
01 Dec 2011
Impresso dental impression 6123
FastSet dental impression 6223
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SuperSet dental impression 6323
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Document Requirements
Class B application
DGT: Dental Cement
Cement: Class B
Primers: Class A
Q: What are the dossier requirements for the Class A
device within the class B application? A: The Class A device will follow the Class A dossier
requirement.
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Dental Grouping Terms
No. DGT DGT Description
Dental
cement
1 Dental
cement
Compounds used in dentistry/ orthodontics typically
to bond a dental prosthesis to the anatomy (luting
agent), to form an insulating layer under dental
restorations. It includes accessories e.g. mixing
pad, dispensor and other components required tocomplete the cementing procedure.
2 Dental
cement kit
A collection of components designed to complete a
cementing procedure.
Q:For devices that fall under multi le dental rou in
terms, which grouping term should be used?
A: The device is only required to be submitted using
one of the DGT, 1 or 2. It is the companys choice.
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Dental Rules vs Existing Rules
Q: Can I choose to follow the existing
grouping rules for general medicaldevices?
. ,
Registrants may choose to use either
e ex s ng group ng ru es or a erna ve
dental grouping rules.
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Current SMDR Listings and
Company A has the following applications that can be grouped under 1
Dental Grouping Term:
SMDR ListingsPending Have Not
. .
Products) Applications Submitted
Listing #1
Listing #1
pp ca on#4
pp ca on#4
Device #6Device #6
SMDRListing #2
SMDRListing #2
Application#5
Application#5
SMDRListing #3
SMDRListing #3
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Scenario 1
Company has a new device (#6) that
is o f the same DGT as a registered
product (#1).
Q: Can Company A submit a new
device to an SMDR list ing
1 Dental Grou in Term ?
A: Yes.
Procedure:
. .
2. Submit Change Notification application (Technical Change: addition of models)
and state the Dental Grouping Term. CN Fee payable.
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3. After HSAs review, the listing will be changed to reflect the DGT.
Scenario 2
Company A has 3 registered products that can be grouped under 1
Dental Grouping Term:
SMDR Listings(i.e. Registered
Q: Can Company A combine the 3 SMDR
listings into 1 (1 Dental Grouping Term)?
SMDRSMDRA: Yes. From 1 Jun 2012 onwards
Listing #1Listing #11. Verify that the listings can be combined under 1
Dental Grouping Term.
Listing #2
Listing #2
.
to be retained (e.g. #1). CN application should
include all documents in listing #2 and #3 and
SMDRListing #3SMDRListing #3
added. CN Fee payable.3. After the CN is approved and the SMDR listing
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,
listings (i.e. #2 and #3).
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Scenario 3
Company A has the following applications that can be grouped under 1
Q: Can Company A combine the 2 applications
A: Yes.
roce ure:
1. Verify that the applications can be combined
under 1 Dental Grouping Term.
2. Email HSA the affected job reference numbers
and confirm which application is to be retained
(e.g. app #4).3. HSA will send input request for company A to
add the documents in app #5 to #4.
3. Com an A withdraws a #5.
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Scenario 4
Company A has a new device that falls under the same Dental
Grouping Term as a pending application:
Q: Can Company A submit a new
device to a pending application
(1 Dental Grouping Term)?
,
screening stage.
Procedure:
. .
2. Check status in MEDICS workbench. Email HSA the affected job referencenumber.
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.
device #6.
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Post-market Actions
Q: Any special considerations for post-market supply?
: o ensure racea y, e ev ce propr e ary names an
identifiers should be properly listed in the annex 2 list of
configurations.
Please maintain proper distribution records.
Nameasperdevice Identifier Descriptionlabel
XYZ Impresso cement XYZ-IM111-2G Zinc phosphate ,2g syringe
- - ,
XYZ FastSet cement XYZ-FA033-2G Polycarboxylate, 4g syringe
- - , ,
XYZ PP primer
XYZ Addy Adhesive XYZ-AA44 XYZ Addy adhesive, 2 ml
-
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,
I need help
verify if my dental grouping is correct.
A: Please email the answer to
[email protected] (subject heading: DGT)
with the following info:
- Annex 2 List of Configurations
- Product Labels and IFUs
- Answers to the decision flow
-
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Dental Products that Require
Examples: Fluoride gels to prevent dental caries, hydrogen
peroxide bleaching agents
- -
Q: Is it intended for a medical procedure or treatment as specified
in the Health Products Act (for a medical device) and Medicines
Act (for a medicinal product)?
Q: Does it contain a scheduled Poison?
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Dental Products that Require
Search for similar products:
Registered medicinal products and Notified Cosmetic Products:
http://www.hsa.gov.sg/publish/hsaportal/en/services/prism/infosea
.
Please verify with HSA using the Health Product Enquiry Form.
Respective Branches will advise you:
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regul
_ _ .
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Dental Products that Require
HSA GN-13: Guidance on risk classification of general medical
devices
.
animal cells, tissues and/or derivatives thereof, rendered non-
viable, or
,
are Class D .
Note: Devices incorporating human cells/tissue: CTT framework
E.g: Bovine hemostatic sponges, dental regenerative membrane
High biological risks
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In-depth review is required
Special Authorisation
Import of dental devices by a PHMC-licenced entity (e.g. dentistry
cen re n a osp a :
1 Special Authorisation application:
GN-27: Authorisation Route for Supply on Request of PHMC-Licensed Facility
- multiple devices
- multiple imports within the 6 month validity period
- di erent risk class
Pre-requisite: valid Importers Licence
At the end of authorisation, importer shall declare the number of
devices imported and supplied.
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Product RegistrationSTART
No need to register
Yes
medical device?
device.
Comply with all other
No
Do I need to register my
may apply.
Yes
Grouping of medical
devices completed?
Register the medical
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device
Product Registration
Summary of steps for Product Registration application
1. Apply for a CRIS company account for Medical Device Information and
Communication System (MEDICS),
Link:http://eservice.hsa.gov.sg/osc/cris/welcome.do
2. Apply for the Registrants Account through MEDICS@HSA
3. Submit Product Registration Application through MEDICS
Specifically, for product registration, please refer to the following documents:
GN-15 Guidance on Medical Device Product Registration
-
General Medical Devices using the ASEAN CSDT
GN-13 Guidance on the Risk Classification of General Medical Devices
Important note
For dental products that contain pharmaceutical components (e.g. filling materials with theantibiotic tetracyclin), please verify with HSA whether registration as combination product
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Thank youThank you
sa_m _ n o sa.gov.sg
HSAs website
- s
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8.Dental caries detector, electricalimpedance
A device designed to measure resistance to the flow of electriccurrent across teeth for the diagnosis of early stage dental cariesand/or to monitor the progress of caries (carious areas being lessresistant due to higher concentrations of fluid). It typically consistsof a probe with an electrode placed in contact with the tooth to betested and a second counter electrode, separate from the probe,which is placed in contact with another part of the patient's body tocomplete an electrical circuit connecting the two electrodes; andan electronic control unit that quantifies the resistance. Thisprocedure is also known as electronic cariesmonitoring/measurement (ECM).
9.Dental caries detector, optical inducedfluorescence
A device designed to determine the changes in the fluorescenceof teeth enamel and dentine due to mineral loss, mainly for thediagnosis of early stage dental caries and/or to monitor theprogress of caries. It consists of a light source (typically a laser)that elicits fluorescence in teeth, and a unit that quantifies thealtered fluorescence of the carious tooth tissue.
10. Dental caries removal solutionA liquid substance used in dentistry to detect and remove cariesfrom an infected tooth. After application, this device cannot bereused.
11. Dental casting materialsCompounds associated with the formation of a dental cast [i.e. apositive copy of a part of the oral anatomy made in an impression(mould)].
12. Dental cavity liner
A substance intended to be applied to the interior of a preparedcavity before insertion of restorative material, such as amalgam, toprotect the pulp of a tooth from chemical irritation. The device istypically a thin layer of zinc oxide (ZnO) and eugenol (C10H12O2),or calcium hydroxide (Ca(OH)2). After application, this devicecannot be reused.
13. Dental cement
Compounds used in dentistry/ orthodontics typically to bond adental prosthesis to the anatomy (luting agent), to form aninsulating layer under dental restorations. It includes accessoriese.g. mixing pad, dispensor and other components required tocomplete the cementing procedure.
14. Dental cement kitA collection of components designed to complete a cementingprocedure.
15. Dental crowns/ bridgesA collection of solid blocks or liquid materials used to manufacture
partial or full crowns and bridges.
16. Dental dry field device
A pre-assembled device used in orthodontic and restorativedentistry to maintain a dry oral cavity for treatment procedures. Itforms a frame around the oral cavity and provides the operatorwith easy access to the field of operation by holding the mouthopen, displacing the tongue, and removing saliva during variousprocedures (e.g., bonding orthodontic brackets, bleaching,applying veneers or pit and fissure sealants, posteriorrestorations). It typically consists of cheek retractors, a tongueguard, suction adaptors, and tubing with Y-piece connection to asuction system; it is reusable after appropriatecleaning/sterilization.
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17. Dental dry field kit
A collection of devices and supplies used in orthodontic andrestorative dentistry to maintain a dry oral cavity for treatmentprocedures. It provides the operator with easy access to the fieldof operation by holding the mouth open, displacing the tongue,and removing saliva during various procedures (e.g., bonding
orthodontic brackets, bleaching, applying veneers or pit andfissure sealants, posterior restorations). It typically consists of biteblocks, pad extenders, suction tips of varying sizes, and tubingthat connects to a suction system. It is reusable after appropriatecleaning/sterilizing, and consumable products may be replenished.
18. Dental etching compositeAcid as solution in water or as gel which is used to create aretentive surface for a composite, an adhesive or a pit and fissuresealant.
19. Dental implant debridement brush
A sterile rotary dental instrument designed for the debridement of
a patient's dental implants affected by peri-implantitis; adestructive inflammatory process of the soft and hard tissuessurrounding dental implants. It is a brush-like device, typicallyconsisting of titanium bristles at the distal end of a high-grade steelshaft, that is held in a dental handpiece which provides its rotationfor the mechanical removal of biofilm from the surface of theimplants. This is a single-use device.
20. Dental implant extractor
A manually-operated, dental device used to retrieve a dentalimplant, typically because of damage (e.g., a broken collar) ormalfunction, from the oral cavity. It is typically made of toughened,high-grade steel and has a cylindrical design with a coarse, left-handed fluting with a steep pitch that spirals up the tapered
working end and a hexagonal head at the proximal end that fits atorque wrench socket. Such a device is inserted into the implant tobe removed and turned anticlockwise (counterclockwise). Theanticlockwise torque exerted makes this device grip into theimplant, which is then unscrewed. It is a single-use device.
21. Dental implant, accessories
A collection of accessories designed to be used for the surgicalplacement of a dental implant into alveolar and/ or basal bone ofthe mandible or maxilla to provide support and a means ofretention for a dental prosthesis (e.g., bridge, single-tooth,overdenture).
22. Dental implant, prosthetic teeth bar A small rod, usually cast or brazed, that bears prosthetic teeth andallows them to be attached to the dental implant abutments.
23. Dental implant, suprastructure
A prefabricated device that is incorporated into, or creates, asuprastructure on dental implants to mimic preparations of naturalteeth. It is used during dental implant restorative procedures andwill provide the permanent intermediate fixture level between thedental implant and the final restoration (e.g., bridge, single tooth,overdenture). The device can be used for, e.g., cement or screwretained restorations and will include, e.g., abutments andcylinders. It comes in a variety of shapes and designs and can bemade of different materials (e.g., titanium, plastic, gold alloy). Alsoincludes temporary suprastructures.
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24.Dental implant/prosthesis, surgicalprocedure kit
A collection of various dental instruments designed for the surgicalplacement of dental implants or prostheses. It does not containpharmaceuticals. It typically contains various dental drills (drillbits), drill extensions, depth gauges, wrenches and torque wrench,screwdrivers, forceps, trays and osteotomes.
25. Dental impression materials
A material designed to reproduce the structure of a patient's teethand gums, or other oral anatomy, after being placed on animpression tray and inserted into the mouth. This is a single-usedevice and includes accessories that are used specifically with thematerial.
26. Dental precision attachmentsDental devices designed for attaching a fixed or removableprosthesis to the crown of an abutment tooth, dental restoration(including implants), or dental appliance.
27.Dental procedure console andaccessories, hydraulic (for use withhandpieces)
An assembly of devices designed to bore and excavate bones,
teeth, and tough tissues during a dental surgical procedure. Ittypically consists of a motorized drill handpiece and/or motor, acontrol unit, and a variety of attachments used to hold thedrilling/excavating instruments (e.g., drills, burs, polishing disks).The system is powered by pressurized water via a connectinghose to the handpiece/motor water-driven turbine. This is areusable device
28.Dental procedure console andaccessories, line-powered (for use with
handpieces)
An assembly of devices designed to bore and excavate bones,teeth, and tough tissues during a dental surgical procedure. Ittypically consists of a motorized drill handpiece and/or motor, acontrol unit, and a variety of attachments used to hold thedrilling/excavating instruments (e.g., drills, burs, polishing disks).
This system is electrically-powered from the mains (e.g., 230 or115 volt) and supplies the handpiece/motor with low-voltageelectricity (e.g., 24 volt) through a control unit. This is a reusabledevice.
29.Dental procedure console andaccessories, pneumatic (for use withhandpieces)
An assembly of devices designed to bore/excavate bones andtough tissues (e.g., cartilage, ligaments) during a surgicalprocedure. It typically consists of a motorized drill handpieceand/or motor, a control unit, and a variety of attachments used tohold the drilling/excavating instruments (e.g., drills, burs,screwdriver bits, and guide wires). The system is pneumatically-powered (gas-powered) by either nitrogen (N2) or surgical-gradeair via a connecting hose to the handpiece/motor. This is a
reusable device.
30. Dental procedure handpiece, hydraulic
A hand-held dental device that includes a chuck for attachingdental drills, burs, reamers, and similar rotating instruments usedto bore/excavate bones, teeth, and tough tissues in dentistry. Thedevice incorporates a small water-powered turbine motor that isdriven by a source of pressurized water; it will typically have abuilt-in water spray for cooling the rotating instrument. It is typicallyconnected to a dental delivery system or a free-standingindependent system. This is a reusable device
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31.Dental procedure handpiece, line-powered
A mains electricity (AC-powered), hand-held, dental device thatincludes a chuck or collet for attaching a dental drill, bur, reamer,and other similar rotating instruments used in dentistry tobore/excavate bones, teeth, and tough tissues. It is powered by alow-voltage electric micro-motor (e.g., 24 volt) that is an integralpart of the device. It is typically connected through the dentaldelivery system or a free-standing independent control unit. This isa reusable device.
32. Dental procedure handpiece, pneumatic
A hand-held device used in surgery for drilling, cutting, andinserting procedures involving bones and tough tissues (e.g.,cartilage, ligaments). It will typically include a built-in motor and achuck for attaching drills, bone taps or wires. The device may becannulated to allow for use of a guidewire and may be of the microor macro design. It is pneumatically-powered (gas-powered) byeither nitrogen (N2) or surgical-grade air via a connecting hose tothe handpiece. This is a reusable device.
33. Dental pulp testing electrode gel
An electrode gel for pulp testers is a device intended to be appliedto the surface of a tooth before use of a pulp tester to aidconduction of electrical current. After application, this devicecannot be reused.
34. Dental pulp-capping material
A dental compound designed to cover an exposed or nearly-exposed dental pulp (e.g., due to deep cavities) to provideprotection against external influences and to promote healing. Thiscompound does not have dental cement or dental cavity linerintended uses. This is a single-use device.
35. Dental reinforcing fibre
A device used in general restorative dentistry and orthodontictreatment typically as reinforcement of dental polymer-basedmaterials, used for the construction of dental prostheses, i.e.,splints, posts, crowns, and bridges. This device is typically madeof polyethylene fibres supplied in strands, braid, or ribbon in avariety of sizes. It may also be used for the stabilization of avulsedteeth maintaining diastema closures or split-tooth syndrome. Theultrahigh molecular weight polyethylene fibres increase thestrength of composite materials, and provide improved safety byassisting in the retention of pieces in the event that a dentalprosthesis is broken. This is a single-use device
36. Dental restorative / cavity varnish
A liquid substance used to cover dental filling material in the initialsetting period after application typically to prevent moistureinfiltration (especially when a dental silicate or glass ionomercement is used as a filling material). The device typically consistsof dissolved artificial resins. It is used for the protection of pulpaltissue and to provide a marginal seal to newly placed amalgamrestorations. After application, this device cannot be reused.
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37. Dental restorative materials
Liquid compounds specially designed to fill dental cavities, restoredamaged dental tissues, or for inlays, onlays and veneering. Itincludes accessories that are used specifically with the materials.It includes accessories e.g. mixing pad, dispensor and othercomponents required to complete the restorative procedure. It
does not include obturation of root canal.
38. Dental restorative/ repair kitA collection of components designed to fill dental cavities orrestore dental tissues. It does not include obturation of root canal.
39. Dental retention pin
A device intended to be placed permanently in the tooth to provideretention and/or stabilization for a dental restoration, e.g., a fillingor a crown. It is typically made of stainless steel or titanium andcomes in a variety of sizes, e.g., 1.0 mm to 3.2 mm. The device isinserted into a pre-drilled hole in the tooth and is secured bythreading, friction and/or cementing.
40. Dental retention pin kit
A collection of various dental instruments, devices and materialsintended for the insertion of permanent pins in healthy dentin toprovide retention and/or stabilization of dental restorations such asfillings and crowns. It is typically presented as a kit and contains,e.g., retention pins of incrementing sizes, a selection of dentaldrills, and the necessary instruments to facilitate the procedure.This is a reusable device.
41. Dental scalers, ultrasonic
Consists of handpieces and scaler tip/insert (which function aspart of an ultrasonic scaler system) that together transmitultrasonic energy (e.g., 25kHz/30kHz) from a generator to the oral
cavity for the removal of accretions from tooth surfaces duringdental cleaning or periodontal therapy. Water or a rinsing solution(e.g., chlorhexidine) is also fed through the handpiece andattached tip to assist in the process. This device is typicallydesigned with permanently attached cables in the form of a pen orpencil. This is a reusable device.
42. Dental scalers, rotary
An abrasive device intended to be attached to a powered dentalhandpiece that provides rotation and is used to remove calculusdeposits and other accretions from tooth surfaces during dentalcleaning and periodontal (gum) therapy. This is a reusable device.
43. Dental scalers, pneumatic
Consists of handpieces and scaler tip/insert, designed to usecompressed air to generate a vibrating action at its point of patientcontact for the removal of accretions from tooth surfaces duringdental cleaning or periodontal therapy. Water is also fed throughthe handpiece and attached tip to assist in the process. It istypically designed with a standard 2-, 3-, or 4-hole connectorutilizing the same connection to existing air driven handpiecetubing and the water spray for lavage. This is a reusable device.
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49. Dental sealants, pit/fissure
A resin-based dental material suitable for sealing pits and fissureson teeth. It may be chemically cured or external energy cured.After application, this device cannot be reused. It may includeaccessories e.g. mixing well, brush etc or other componentsrequired to complete the sealing procedure.
50. Dental shaded pontic kit
A collection of devices intended to be used to produce artificialtooth veneers (shaded pontics) typically inside clear plasticcustom-made teeth aligners (retainer-style orthodonticappliances). This is used to create the appearance of teeth insidethe aligner to cover spaces where teeth may be missing foraesthetic purposes during treatment to realign teeth. The contentsof the device may include polymer-based materials, dispensergun, mixing tips, applicator brushes and practice aligner.
51. Denture claspsDental devices designed to retain and stabilize removable partialdentures to stationary teeth.
52. Denture reliners
A device consisting of polymer based material, e.g. plastic resin,that is applied as a permanent coating or lining on the base ortissue-contacting surface of a denture. Denture relining is definedas a process of providing a new fitting surface to a denture.
53. Facebow
A caliper-like dental instrument used to record the relative positionof the maxillary arch to the temporo-mandibular joint (TMJ), or theopening axis of the jaw. It is used to orient dental casts in thesame relationship to the opening axis of the articulator.
54. Fixture/appliance dental drill, single-use
A sterile shaft of metal (a drill bit) intended to be used in dentalsurgery to create channels of appropriate depth and diameter inbone (osteotomy) of the oral cavity to facilitate the implantation ofa dental fixture/appliance. It is typically made of a high-gradestainless steel alloy. The device is typically available in a set ofgraduated sizes and various forms and functions (e.g., guide, pilot,twist, cortical, conical). It is attached to a motorized handpiece orother power source that provides rotation. This is a single-usedevice that is intended, in terms of sterility, for a single-patient use.
55. Gingiva bleaching protector
A non-sterile paste or gel-like substance designed to protect a
patient's gums from the hydrogen peroxide found in teethwhitening agents used during chairside light-curing bleaching ofthe teeth. It is typically supplied in a disposable syringe and isapplied with an applicator along the gingiva leaving the teethexposed for treatment. After application, this device cannot bereused.
56. Gingival retraction cord, non-medicatedA non-medicated, cotton string used to temporarily hold off thegingiva during abutment preparation. This is a single-use device
57. Gingival retraction kitA collection of sterile dental instruments and other items used tohold off the gingiva during abutment preparation. This is a single-
use device.
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58. Gingival retraction solution
A liquid substance used in dentistry to induce gingival retraction byin situ impregnation of a non-medicated gingival retraction cord. Itinduces contraction of the upper strata of the free gingiva. Thisdevice may also induce a local stasis of gingival exudates andgingival haemorrhages. After application, this device cannot be
reused.
59.Non-medicated dental surgical procedurekit, single-use
A collection of various sterile dental instruments, dressings andthe necessary materials used to perform a dental surgicalprocedure. It does not contain any pharmaceuticals. This is asingle-use device.
60. Oral wound dressing, non - animal/microbial- derived
A non-sterile compound intended as a protective cover for the oralmucosa to manage wounds and sores in the mouth. It is used forvarious types of dental wounds and sores such as oral ulcers(non-infected or viral) and lesions caused by dentalprostheses/orthodontic braces; it may also be used to treat
mucosal irritations/inflammation, dryness and gingivitis. It issupplied in various forms (e.g., gel, paste, fluid, spray solution ofwater/oil). It is normally available [non-prescription] over-the-counter (OTC) for use in healthcare facilities or home. Afterapplication, this device cannot be reused. This does not includepharmaceuticals.
61.Orthodontic appliance archwire-cooling
device
An instrument used in orthodontic dentistry to intra-orally chill orcool thermally-activated archwires when placing bends in anorthodontic appliance. The device, after it has been precooled(typically with a cryogenic spray), is applied to a desired point ofcontact on the wire to extract heat and allow easy bending. As the
archwire warms to body temperature it attempts to return to itsformer shape, and thus contributes to the application of forceswithin the mouth. The device is typically formed as a heavy-dutystainless steel rod with an insulated plastic handle and a slot atthe distal end to accept wire.
62.Orthodontic appliance force-measuringgauge
An instrument used in orthodontic dentistry to accurately measureforces (in grams or ounces) applied by the elastics or springs usedwhen setting up orthodontic appliances within the patient's mouth.The device is typically of cylindrical or tubular design (but can bedial-shaped with circular read out) and is made of metal (somepartly plastic); it contains a spring-loaded mechanism whichindicates the force exerted to pull the appliance elastic or spring to
the desired length.
63. Orthodontic appliances
Dental devices designed to influence the shape and/or function ofthe stomatognathic system through the application of physicalforce. It includes orthodontic anchor plate, orthodontic anchoringscrew, orthodontic archwire, orthodontic archwire/bracket fixationring, orthodontic bands, orthodontic brackets, orthodontic bracketadhesive, orthodontic clasps, orthodontic chin cap, orthodonticextraoral headgear, orthodontic face bow, orthodontic ligature,orthodontic magnet, orthodontic spring, orthodontic tube,orthodontic wire.
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71. Root canal posts
A dental device (rod) intended to be inserted and cemented into aprepared root canal of a tooth to stabilize and support arestoration. Pre-fabricated root canal posts come in variousshapes and dimensions, as well as materials, e.g. metal, fibrereinforced polymer and ceramic.
72. Root surface conditioner
A dental material, typically of neutral pH, used for topicalapplication on exposed/scaled root surfaces for the removal of thesmear layer (adherent debris produced when cutting the enamel ordentin in cavity or endodontic preparation, Circa 1 micron thick)during dental/periodontal surgery. The material is removed(washed off) after the recommended period to expose thecollagenous matrix of dentine surfaces. It is typically presented inthe form of a gel and consists of, e.g., edetate disodium (EDTA)and carboxymethylcellulose (CMC) with a neutral pH. Afterapplication, this device cannot be reused.
73. Tooth preservation kit
A convenient collection of sterile devices/supplies designed topreserve and transport a tooth that has been knocked out (i.e.,avulsed) so it can be reimplanted. It typically includes instruments,preserving solutions, a container (e.g., a vial or cup with a plasticnet inside to hold the tooth suspended in the preservationsolution), and swabs/bandages. It is used to avoid tooth cellcrushing and/or dehydration by immersing the tooth in a pHbalanced solution compatible with periodontal cells, and is typicallyused in field emergency situations after traumatic knock out ofteeth. This is a single-use device.
74.Warm-bonded endodontic obturationsystem
An assembly of devices designed to deliver preheated resin-basedsealing, filling, and core materials into a root canal for direct warmbonding during an endodontic obturation procedure. It typicallyconsists of a mains electricity (AC-powered) oven specifically usedto heat the preloaded oburators, a series of root canal sizers(verifiers) used for the selection of the appropriate obturator, andpreloaded obturators; other materials may be included (e.g., self-etch sealer).
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