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DEKRA Certification B.V. j B.T.M. Holtus ¦ J.A. van Vugt Managing Director Certification Manager © Integral publication of this certificate and adjoining reports is allowed The validation of the validity of this certificate can be checked through DEKRA's website using the following link: https:/www.dekra-product-safety.comencertified-organizations DEKRA Certification B.V. is recognized under the Medical Devices Single Audit Program. DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netherlands T +31 88 96 83000 F +31 88 96 83100 www.dekra-certification.com Company registration 09085396 Page 1 of 1 CERTIFICATE Number: 3823124 The management system of: DentalEZ, Inc. StarDental Division 1816 Colonial Village Lane Lancaster, PA 17601 United States Of America Manufacturer DUNS 059010363 Conforms with the following standard and regulatory requirements: ISO 13485:2016 Canada: Medical Devices Regulations - Part 1- SOR 98/282 United States: 21 CFR 803, 21 CFR 806, 21 CFR 807 - Subparts A to D, 21 CFR 820 Scope: Design, manufacture and service of high & low speed dental handpieces, sonic scalers, hand-held instruments; light based adjunctive screening devices for oral cancer. Certificate expiry date: 2021-11-19 Certificate effective date: 2018-11-19 Certified since: 2018-11-19

CERTIFICATE - dentalez.com€¦ · CERTIFICATE Number: 3823124 The management system of: DentalEZ,Inc.StarDentalDivision 1816 Colonial Village Lane Lancaster, PA 17601 United States

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Page 1: CERTIFICATE - dentalez.com€¦ · CERTIFICATE Number: 3823124 The management system of: DentalEZ,Inc.StarDentalDivision 1816 Colonial Village Lane Lancaster, PA 17601 United States

DEKRA Certification B.V.

jB.T.M. Holtus

¦J.A. van Vugt

Managing Director Certification Manager

© Integral publication of this certificate and adjoining reports is allowed

The validation of the validity of this certificate can be checked through DEKRA's website using the following link:

https:/www.dekra-product-safety.comencertified-organizations

DEKRA Certification B.V. is recognized under the Medical Devices Single Audit Program.

DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netherlands

T +31 88 96 83000 F +31 88 96 83100 www.dekra-certification.com Company registration 09085396

Page 1 of 1

CERTIFICATENumber: 3823124

The management system of:

DentalEZ, Inc. StarDental Division1816 Colonial Village LaneLancaster, PA 17601United States Of America

Manufacturer DUNS 059010363

Conforms with the following standard and regulatory requirements:

ISO 13485:2016Canada: Medical Devices Regulations - Part 1- SOR 98/282

United States: 21 CFR 803, 21 CFR 806, 21 CFR 807 - Subparts A to D, 21 CFR 820

Scope:Design, manufacture and service of high & low speed dental handpieces, sonic scalers, hand-held instruments; light based adjunctive screening devices for oral cancer.

Certificate expiry date: 2021-11-19Certificate effective date: 2018-11-19Certified since: 2018-11-19