RePlant Surgical Trays packaged withVariable Band Depth (VBD) markings on Long Drill

Date: 7-29-08 To: Implant Direct Customers

Subject:

Product Release: RePlant® Surgical Tray (RCST and RBST)

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2 7 0 3 0 M a l i b u H i l l s R o a d , C a l a b a s a s H i l l s , C A 9 1 3 0 1

P h o n e : 8 1 8 . 4 4 4 . 3 3 3 3 o p t 2 : 8 8 8 - N I Z N I C K ( 6 4 9 - 6 4 2 5 ) F a x : 8 1 8 . 4 4 4 . 3 4 0 0

RePlant Complete and Basic Surgical Tray now available!!!!

The RePlant Surgical Tray is designed for use with Implant Direct RePlant System. The RePlant

System of implants was launched to be used with the NobelReplace™ Tapered Implant System

surgical tray. But, due to the high cost of the surgical instrumentation from this competitor, Implant

Direct decided to produce their own custom surgical tray. The tray will provide our current and future

RePlant users as well as Nobel Tapered Implant users with a cost effective alternative.

The unique design of step drills for soft and dense bone protocols enables clinicians to place

implants using one final drill per diameter to place all lengths of implants. A system of 14 drills

(including long and short versions) simplifies the process to place 4 lengths of implants in all 4

diameters in all areas of the mouth. Laser marking, color coded tray sections, grommets and some

tools, aid in easy identification of diameter specific components within the tray.

The system is supplied with a full ancillary set of tooling providing the clinician with an assortment

of placement options. Paralleling Pins, Insertion and Hex Tools, Drill Extender as well as Ratchet

and Handle are all included in the set. Many of these components are compatible with other

systems within the Implant Direct’s product offering allowing the clinicians the flexibility to place

a variety of different implant designs with minimal additional investment.




New Laser/Matte marked drills are now available!!!!

The RePlant Complete (RCST) and Basic (RBST) Surgical Trays are available with the

drills that have the variable band depth (VBD) markings.The depth marking

system, composed of a combination of electropolish, matte finish, laser bands and laser

lines, separates the drill into clearly distinguishable areas.The drills are textured to

facilitate implant site preparation when utilizing single length drills to place a variety of

implant lengths.The variable band depth (VBD) markings allows the clinician at a

moments notice to determine to what length they have progressed sub-crestally no

matter at what level the drill is in the osteotomy.

The apical 6-7mm of the drill is electropolish (shiny), followed by a 2mmLmatte band to allow for 8mm implant placement.The following section is a 2mmLlaser band which would indicate a 10mmL implant placement.The 3mmL matte

section is bisected by a laser line at 11.5mmL (this line is not required for place-

ment of RePlant implants).The top of the 3mmL matte section indicates the area for

13mmL implant placement.The 3mmL laser band above this area allows for the

16mmL implant placement.

for 16mmL implant

for 13mmL implant

for 10mmL implant

Soft Bone Drills with Variable Band Depth (VBD) markings

These drills are designed to be used as the final drill in the sequence

of placing RePlant Implants in soft bone.There is a specific Soft Bone

Drill for each diameter of implant, namely 3.5mm, 4.3mm, 5.0mm and

6.0mm.A single Soft Bone Drill is used for all lengths of implants per

implant diameter.The diagram below indicates the Variable Band Depth

demarcations on the drill that would be applied to each implant length.

Drill osteotomy to the top of the score line or band to ensure full seating

of implant.

These drills are available in long and short versions accommodating for

implants to be placed in areas of limited vertical clearance.

for 8mmL implant




3.5mmD Implant 4.3mmD Implant 5.0mmD Implant 6.0mmD Implant

603508-16RePlant Implant,




for 16mmL implant

for 13mmL implant

for 10mmL implant

Dense Bone Drills with Variable Band Depth (VBD) markings

These drills are designed to be used as the final drill in the sequence of

placing RePlant Implants in dense bone.There is a specific Dense Bone

Drill for each diameter of implant, namely 3.5mm, 4.3mm, 5.0mm and

6.0mm.A single Dense Bone Drill is used for all lengths of implants per

implant diameter.The diagram below indicates the Variable Band Depth

demarcations on the drill that would be applied to each implant length.

These are not proportional spacings as the design is also based on a

pre-calculated amount of thread engagement in the surrounding bone

each implant length requires using the same drill.

for 8mmL implant




3.5mmD Implant 4.3mmD Implant 5.0mmD Implant 6.0mmD Implant





Manufactured from stainless steel, the tool is

designed to assist in the rotation of the implant

into the osteotomy. Inserting the tool into the

multi-level implant connection enables the clinician

to use an alternate method for delivery and

final placement of tri-lobe implants.

When the fixture mount is not present; either

by removal chair side or by using implants that

do not have the mount in their original packaging,

the lower level tri-lobe section of the tool will

engage the tri-lobe within the implant.The

PEEK plastic split O-ring at the tip of the tool

will frictionally engage the implants cylindrical

channel, enabling the clinician to carry the

implant to or from the surgical site.

During flapless surgery the series of platform

specific colored lines combined with the tool’s

geometries, assists the clinician in placing the

implant level with the crest of the ridge.This is also used as

an indicator for selecting the appropriate length healing

components and/or abutment cuff heights.

The upper level tri-lobe on the tool provides a clear indicator

of the rotational position of the implants tri-lobe.The clinician

rotates the tool to place the lobes in the position best suited

for abutment placement and prosthetic rehabilitation.




3.5mmD Platform 4.3mmD Platform 5.0mmD Platform 6.0mmD Platform

PEEK Split O-ring

Lower level tri-lobe

Upper level tri-lobe

Chord retention groove

Square connection for usewith Ratchet [R]

2mmL soft tissuescore line

1mmL soft tissuedemarcation

3mmL soft tissuescore line

4mmL soft tissuedemarcation

Tri-Lobe Insertion Tools [RTT]

RTT3 RTT4 RTT5 RTT6

18.5mmLabove implant

platform


1. Obtain access to the drill site using a

tissue punch to remove a section of soft

tissue corresponding in dimension to the

implant to be placed.

1. Remove healing component to expose the

top of the implant.

3. Attach abutment and torque to 30Ncm.

Follow routine prosthetic procedures to

complete final prosthesis.

Tri-lobe Insertion Tool [RTT] Technique SheetUse of Tri-lobe Insertion Tool during flapless surgery

Use of Tri-lobe Insertion Tool for abutment selection

2. Place a perioprobe or alternate measuring device into the open site to determine the depth of

soft tissue. The Tri-lobe Insertion Tools have colored score lines and tool geometries to enable the

clinician to visually determine 1mm, 2mm, 3mm and 4mm heights of surrounding soft tissue during

the insertion process.

2. Use Tri-lobe Tool to determine height of

surrounding soft tissue relative to implant

platform. Select abutment based on cuff

height requirement for final prosthesis.

3. Follow the drill sequence chart to prepare

the osteotomy for placement of corresponding

diameter of implant.

7. The implant is placed level with the crest

of the ridge or as determined by the clinician.

6. Use the upper level tri-lobe of the tool to

obtain the desired orientation of the implants

tri-lobe relative to surrounding dentition.

5. Use the Ratchet [R] to rotate the tool until

implant is fully seated. The tools height

demarcations assist in placing the top of the

implant level with the crest of the ridge.

2mmL

2mmL3mmL

4. Select the implant for placement into the prepared osteotomy. Carry the implant to site using the

attached fixture mount or with the color coded Tri-lobe Insertion Tool [RTT] for mount less delivery.

Tri-lobe Insertion Tools can be used on all implants with compatible tri-lobe connections.

Upper level

tri-lobe

RTT

3RT

T4

RTT

5RT

T6

DE

SD2.

8SD

2.8S

RD

B3

TH

T1.

25

PAR

(Qua

ntit

y of

4)

D2.

3S

LDR

ILL

R

RSB

6R

SB6S

RD

B6

SSH

TH

T1.

25S

HT

1.25

D2.

3

HD

2.5

HD

1.25

HT

1.25

SFM

D

RSB

5R

SB5S

RD

B5

SD3.

4SD

3.4S

RD

B4

Surgical Tray for Replant ® and NobelReplace ™ Tapered Implants


Surgical Trays - RePlant Complete , Basic and Upgrade Kit

InsideEmpty Surgical Tray:

$350.00

Product Code: RST

Surgical tray contents Complete Kit Basic Kit Upgrade KitCode Description Price $2,105.00 $1,495.00 $610.00

Non-Internally Irrigated Drills

D2.3 2.3mmD Straight Drill-Long $60.00 X X

D2.3S 2.3mmD Straight Drill-Short $60.00 X X

SD2.8 2.8/2.3mmD Step Drill for 3.5mmD Implant $60.00 X X

SD2.8S 2.8/2.3mmD Short Step Drill for 3.5mmD Implant $60.00 X X

SD3.4 3.4/2.8mmD Step Drill for 4.3mmD Implant $60.00 X X

SD3.4S 3.4/2.8mmD Short Step Drill for 4.3mmD Implant $60.00 X X

RSB5 4.2/3.3mmD Step Drill for 5.0mmD Implant $60.00 X X

RSB5S 4.2/3.3mmD Short Step Drill for 5.0mmD Implant $60.00 X X

RSB6 5.1/4.2mmD Step Drill for 6.0mmD Implant $60.00 X X

RSB6S 5.1/4.2mmD Short Step Drill for 6.0mmD Implant $60.00 X X

Dense Bone Drills

RDB3 Dense Bone Drill for 3.5mmD Implant $60.00 X X




Hex Tools

THT1.25 1.25mmD Tapered Hex Tool-Long $40.00 X X

THT1.25S 1.25mmD Tapered Hex Tool-Short $40.00 X X

HT1.25 1.25mmD Straight Hex Tool-Long $40.00 X X

HT1.25S 1.25mmD Straight Hex Tool-Short $40.00 X X

HD1.25 1.25mmD Hex Drill $40.00 X X

HD2.5 2.5mmD Hex Drill $40.00 X X

Tri-Lobe Insertion Instruments

RTT3 Tri-Lobe Insertion Tool for 3.5mmD Implant $60.00 X X




Insertion Instruments

FMD Fixture Mount Drill $80.00 X X

LDRILL Locator Drill $30.00 X X

DE Drill Extender $40.00 X X

R Ratchet $125.00 X X

PAR (x4) Paralleling Tool 2.8/2.3 $60.00 X X

SSH Stainless Steel Handle $100.00 X X

Lid





Tapered Hex Tools

The 1.25mmD (0.050”) Tapered Hex Tool [THT1.25,THT1.25S]

has a hexed tip which is tapered providing frictional engagement

with the internal straight walls of Surgical Cover Screws or

other prosthetic screws with similar connections.The

connection between the tool and screw allows the clinician to

carry the component to and from the mouth without the

screw separating from the tool during transit.

The opposing end of the tool incorporates a flat top thumb

wheel allowing for free rotation of the tool.The index finger

from the one hand will hold the tool in vertical position while

the tool is rotated with the other hands thumb and index finger.

Note:This tool can be used to finger-tighten components but

cannot provide the higher levels of torque required for long

term prosthetic screw stability.

Straight Hex Tools

The 1.25mmD (0.050”) Hex Tool [HT1.25, HT1.25S] has a

hexed tip which is straight and passively engages the internal

straight walls of Surgical Cover Screws or other prosthetic

screws with similar connections.

The opposing end of the tool has a industry standard square

connection allowing it to be inserted into most prosthetic

torque wrenches [TW30,TW35].The black 0-Ring provides

frictional stability between the Torque Wrench and Hex Tool.

Note:This tool can be used to finger-tighten components

and in combination with the corresponding Torque Wrench

provides the higher levels of torque required for long term

prosthetic screw stability.

This tool is not to be used with a Ratchet [R].

Tapered 1.25mmD hex tip

Thumb Wheel

Knurled Handle

Shaft14mmL - long version9mmL - short version

Head of tool is 14mmL

Straight 1.25mmD hex tip

Square connection

Chord retention groove

Black O-Ring

Shaft14mmL - long version9mmL - short version

Head of tool is 8mmL




2.5mmD Straight Hex Drill

The 2.5mmD Hex Drill [HD2.5] has a hexed tip which is

straight and passively engages the internally hexed

fixture mount supplied with most of Implant Directs system

of implants.

The drill has an additional hex above the 2.5mmD hex.This

hex is used in the visual determination of the orientation of

the hex within the internally hexed implant systems.

The opposite end of the tool is designed with a industry

standard latch head connection to be used with a motor or

hand driven contra-angle hand piece,Torque Wrench / Ratchet.

1.25mmD Straight Hex Drill

The 1.25mmD (0.050”) Hex Drill [HD1.25] has a hexed tip

which is straight and passively engages the internal straight

walls of Surgical Cover Screws or other prosthetic screws

with similar connections.


standard latch head connection to be used with a motor or

hand driven contra-angle hand piece,Torque Wrench / Ratchet.

Note:This tool is often recommended to Nobel clinicians

who are using our system for the first time.


9mm height

Latch Head connection

Hex configuration todetermine orientation

Standard Drill shank


10mm height






Locator Drill [LDRILL]

The Locator Drill is used as the preliminary drill when

preparing the osteotomy. Clinicians prefer to use a drill which

has a sharp point to prevent it from slipping on the dense

cortical plate prior to perforation. During flapless surgery this

drill is used to perforate the soft tissue.The 2.3mm diameter

of the drill will create an osteotomy that will receive the

Paralleling Tool [PAR].


standard latch head connection to be used with a motor driven

contra-angle hand piece.

Note: Please ensure drill is placed point down when inserting

into the tray.

Paralleling Tool [PAR]

Use the Paralleling Tool to ensure that the 3 D spatial

orientation of the osteotomy is correct prior to further

enlargement of site.

Thread floss through the 1mmD thru hole to prevent

accidental aspiration of tool.

Drill the initial 2.3mmD hole with either LDRILL or the

2.3mmD Pilot Drill [D2.3, D2.3S]. Place the 2.3mmD straight

walled side of the tool into the osteotomy.An x-ray evaluation

of the tool in place is made by clinician. If angulation adjustments

are required this is done with the next size drill in the surgical

sequence.The clinician uses the grooved side to determine

the vertical distance to surrounding anatomical landmarks.

Drill the hole with the 2.8mmD stepped or straight drill.

Insert the 2.8mmD groove side of the [PAR] into the osteotomy

and confirm alignment.

Straight walled side2.3mm in diameter

Straight walled side2.8mm in diameter

1mmD thru hole for chord retention

Grooves 2mm apart

Straight section is 9mmL

3.1mmD hub

2.3mm in diameter

17mmL Score line

8mmL Score line

Drill Point






Fixture Mount Drill [FMD]

The internal square feature of the fixture mount drill is

designed to receive the square design of the of the fixture

mount which is attached to most of the Implant Direct’s

Implants.




Connect the FMD to the hand piece set to under 30rpm.

Place open end of tool over the square end of fixture mount

and push down onto fixture mount.The O-ring frictionally

engages the fixture mount enabling the clinician to carry the

implant/fixture mount assembly to site.

Drill Extender [DE]

The Drill Extender increases the length of drills or other latch

head tooling by 16mm.This extension provides access in

between adjacent teeth.The internal feature within the extender

mimics that of a latch head connection within the hand piece.




7.6mm in diameter


O-ring for retention


4.5mm in diameter

16mm height



Dense Bone Drills

Code Description PriceRDB3 Dense Bone Drill for 3.5mmD Implant $60.00RDB4 Dense Bone Drill for 4.3mmD Implant $60.00RDB5 Dense Bone Drill for 5.0mmD Implant $60.00RDB6 Dense Bone Drill for 6.0mmD Implant $60.00

RDB6RDB5RDB4RDB3

RePlant Dri l l Sequence

SOFT BONE

3.5mmD Implant

3.5mmD Implant

D2.32.3mmD

Drill

FINAL DRILLRDB3

3.2mmD

FINAL DRILLSD2.8

2.8/2.3mmD

3.5mmD Straight / Tapered Implant

RePlant 3.5

SOFT BONE

4.3mmD Implant D2.3

2.3mmDDrill

FINAL DRILLRDB4

4.0mmD

FINAL DRILLSD3.4

3.4/2.8mmD


RePlant 4.3

SOFT BONE

5.0mmD Implant

DENSE BONE

5.0mmD Implant

D2.32.3mmD

Drill

FINAL DRILLRDB5

4.7mmD

FINAL DRILLRSB5

4.2/3.3mmD


RePlant 5.0

SOFT BONE

6.0mmD Implant

DENSE BONE

6.0mmD Implant

D2.32.3mmD

Drill

FINAL DRILLRDB6

5.7mmD

FINAL DRILLRSB6

5.1/4.2mmD


RePlant 6.0

SD2.8

SD4.4

SD3.4

SD3.4

RSB5

SD3.4DENSE BONE

4.3mmD Implant

Soft Bone Drills

Code Description PriceD2.3 2.3mmD Straight Drill $60.00D2.3S 2.3mmD Short Straight Drill $60.00SD2.8 2.8/2.3mmD Step Drill for 3.5mmD Implant $60.00SD2.8S 2.8/2.3mmD Short Step Drill for 3.5mmD Implant $60.00SD3.4 3.4/2.8mmD Step Drill for 4.3mmD Implant $60.00SD3.4S 3.4/2.8mmD Short Step Drill for 4.3mmD Implant $60.00RSB5 4.2/3.3mmD Step Drill for 5.0mmD Implant $60.00RSB5S 4.2/3.3mmD Short Step Drill for 5.0mmD Implant $60.00RSB6 5.1/4.2mmD Step Drill for 6.0mmD Implant $60.00RSB6S 5.1/4.2mmD Short Step Drill for 6.0mmD Implant $60.00

SD2.8S

SD2.8

D2.3S

D2.3

SD3.4S

SD3.4

RSB5S

RSB5

RSB6S

RSB6

Surgical Dri l ls : RePlant and NobelBiocare Tapered Implants

RSB6

Code Description PriceR Ratchet $125.00

TW30 30Ncm Torque Wrench $125.00TW35 35Ncm Torque Wrench $125.00SSH Stainless Steel Handle $100.00FMD Fixture Mount Drill $80.00PAR Paralleling Tool 2.8/2.3 $15.00

LDRILL Locator Drill $30.00DE Drill Extender $40.00

Code Description PriceTHT1.25 1.25mmD Tapered Hex Tool Long $40.00THT1.25S 1.25mmD Tapered Hex Tool Short $40.00HT1.25 1.25mmD Straight Hex Tool Long $40.00HT1.25S 1.25mmD Straight Hex Tool Short $40.00HD1.25 1.25mmD Hex Drill $40.00HD2.5 2.5mmD Hex Drill $40.00

Surgical and Prosthetic Ins truments

R SSHTW30 TW35

HD1.25HT1.25THT1.25

HD2.5HT1.25STHT1.25S

Hex Tools

Code Description PriceRCST Complete Surgical Kit for RePlant Implant System $2105.00RBST Basic Surgical Kit for RePlant Implant System $1495.00RUPST Upgrade Kit for RePlant Implant System $610.00

RCST

Surgical Trays

Instruments

PARFMD DELDRILL

RePlant Insertion Tools

Code Description PriceRTT3 Stainless Steel Tri-Lobe Insertion Tool for 3.5mmD Implant $60.00RTT4 Stainless Steel Tri-Lobe Insertion Tool for 4.3mmD Implant $60.00RTT5 Stainless Steel Tri-Lobe Insertion Tool for 5.0mmD Implant $60.00RTT6 Stainless Steel Tri-Lobe Insertion Tool for 6.0mmD Implant $60.00

RTT6RTT5RTT4RTT3

Documents

RePlant Surgical Trays packaged withVariable Band Depth (VBD) markings on Long Drill