EC Certificate - Full Quality Assurance System


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EC Certificate - Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4

No.

CE 516198

Issued To:

Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks California 91362 USA

In respect of:

The design and manufacture of sterile dental implants, dental abutments and related instrumentation.

on the basis of our examination of the quality assurance system under the requirements of Council Directive 93/42/EEC, Annex II excluding section 4. The quality assurance system meets the requirements of the directive. For the placing on the market of class III products an Annex II section 4 certificate is required. For and on behalf of BSI, a Notified Body for the above Directive (Notified Body Number 0086):

Stewart Brain, Head of Compliance & Risk Medical Devices First Issued: 2007-07-19

Date: 2017-07-14

Expiry Date: 2022-07-18

Page 1 of 1 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company named on this certificate, unless specifically agreed with BSI. This certificate was issued electronically and is bound by the conditions of the contract. Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 345 080 9000 BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK. A member of BSI Group of Companies.

EC Certificate - Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4

List of Significant Subcontractors Recognised as being involved in services relating to the product covered by: Certificate No:

CE 516198

Date:

2017-07-14

Issued To:

Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks California 91362 USA

Subcontractor:

Service(s) supplied

Boston Centerless Inc. 11 Presidential Way Woburn Massachusetts 01801 USA

Crucial Supplier

Cendres & Métaux SA CH-2501 Biel-Bienne Switzerland

Manufacture

Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands

EU Representative

HiMed 148 Sweet Hollow Rd Old Bethpage New York 11804 USA

Other critical processes

Page 1 of 3 Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 345 080 9000 BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK. A member of BSI Group of Companies.

EC Certificate - Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4

List of Significant Subcontractors Recognised as being involved in services relating to the product covered by: Certificate No:

CE 516198

Date:

2017-07-14

Issued To:

Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks California 91362 USA

Subcontractor:

Service(s) supplied

Implant Direct Sybron Manufacturing LLC 8840 W. Russell Road Las Vegas Nevada 89148 USA

Distribution Packaging

Norsco Inc 1816 Ackley Circle Oakdale California 95361 USA

Manufacture

Orchid Unique Orthopaedic Solutions 6688 Dixie Hwy. Bridgeport Michigan 48722 USA

Manufacture

Page 2 of 3 Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 345 080 9000 BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK. A member of BSI Group of Companies.

EC Certificate - Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4

List of Significant Subcontractors Recognised as being involved in services relating to the product covered by: Certificate No:

CE 516198

Date:

2017-07-14

Issued To:

Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks California 91362 USA

Subcontractor:

Service(s) supplied

Perryman Company Specialty Titanium Products 18430 Brookhurst St., Ste 202G Fountain Valley California 92708 USA

Crucial Supplier

Rhein 83 S.r.l. Via E Zago n 10 - 40128 Bologna Italy

Manufacture

Sterigenics 344 Bonnie Circle Corona California 92880 USA

Gamma Sterilization

Page 3 of 3 Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 345 080 9000 BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK. A member of BSI Group of Companies.

EC Certificate - Full Quality Assurance System Certificate History Certificate No:

CE 516198

Date:

2017-07-14

Issued To:

Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks California 91362 USA

Date

Reference Number

Action

19 July 2007

-

First issue

16 June 2011

-

Change of company name from Implant Direct LLC to Implant Direct Sybron Manufacturing LLC. Clarification of certificate scope and addition of significant subcontractor Emergo Group, Molenstraat 15 2513 BH, The Hague, Netherlands for EU Representative Activity.

18 July 2012

7867506

Certificate renewal. Addition of significant subcontractors for manufacture activity: Orchid Unique Orthopaedic Solutions; Norsco Inc; EBI Inc. Removal of significant subcontractor Maillefer Instruments.

04 March 2013

7880044

Addition of DOT GmbH as a significant subcontractor following the transfer of products from Attachments International and Sybron Implant Solutions.

21 November 2013

8074224

Added Maillefer Instruments as subcontractor and corrected info for Emergo.

12 January 2015

8207630

Location of legal manufacture has changed to Thousand Oaks, California.

30 June 2015

8350475

Expansion of scope to include manufacture and control of sterile product. Review and approval of clean room at Thousand Oaks facility.

Page 1 of 2 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company named on this certificate, unless specifically agreed with BSI. This certificate was issued electronically and is bound by the conditions of the contract. Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 345 080 9000 BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK. A member of BSI Group of Companies.

EC Certificate - Full Quality Assurance System Certificate History Certificate No:

CE 516198

Date:

2017-07-14

Issued To:

Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks California 91362 USA

Date Current

Reference Number 8744602

Action Certificate Renewal Addition of HiMed as subcontractor for HA coating (Activity type: Other Critical Processes). Addition of Implant Direct Sybron Manufacturing LLC as subcontractor (Activity: Packaging and Distribution) Addition of Perryman Company and Boston Centerless to list of subcontractors (Activity: Crucial Supplier) Update to address for EU Rep Emergo Europe. Remove DOT GmbH, EBI Inc., and Maillefer Instruments from list of subcontractors.

Page 2 of 2 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company named on this certificate, unless specifically agreed with BSI. This certificate was issued electronically and is bound by the conditions of the contract. Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 345 080 9000 BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK. A member of BSI Group of Companies.