No. CE 629233 In respect of: Design and manufacture of sterile dental implants, sterile and non-sterile prosthetic abutments, sterile single use surgical instruments, non-sterile reusable surgical instruments for connection to an active medical device. Those aspects of Annex II related to metrological requirements in the design and manufacture of dental surgical instruments. Those aspects of Annex II related to securing and maintaining sterility in the design and manufacture of dental surgical instruments. 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): Frank Lee, EMEA Compliance & Risk Director First Issued: 19 March 2015 Expiry Date: 08 April 2021 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.
ACNIS Do Rua Ecydir Vieira Soares - 13 JD Amalia / Sorocaba Aços Böhler Uddeholm do Estr. Yae Massumoto, 353 São Bernardo do Campo 09842-160 Companhia eira de Esterilizacao-CBE/Embrarad Cruzada Bandeirante 290 Cotia 06705-140 Gamma Sterilization Page 1 of 5
Esterilizacao de Materiais Medicos-Sterilab Av. Maringá-185 Pinhais 83323-000 Dynamet Inc 195 Museum Road Washington Pennsylvania 15301 USA Fort Wayne Metals Research Products Corporate 9609 Ardmore Avenue Fort Wayne Indiana 46809 USA ETO Sterilization Page 2 of 5
Instradent AG Peter Merian-Weg 12 Basel 4052 Switzerland Ivoclar Vivadent RUA GERALDO FLAUSINO GOMES, 78 BROOKLIN NOVO 04575.060 Mesa Di Sala Giacomo & C. S.N.C. VIA DELL'ARTIGIANATO 35/37/39 TRAVAGLIATO Brescia 25039 Italy EU Representative Page 3 of 5
Metoxit AG Emdwiesenstrasse 6 Thayngen 8240 Switzerland Perryman Company 213 Vandale Drive Houston Pennsylvania 15342 USA Sandinox Rua Pedro Almeida Lima, 700 Eden Sorocaba 18103-040 Page 4 of 5
Titanium Industries 18 Green Pond Rd Rockaway New Jersey 07866 USA Page 5 of 5
Certificate History Date Reference Number Action 19 March 2015 8268106 Transfer from another Notified Body with scope: Sterile dental implants, sterile and non-sterile prosthetic components, sterile and non-sterile surgical instruments and drills 13 July 2015 8348626 Change to EU representative from JJGC Portugal Industria, Comercio E Representação de Materiais Dentários, Sociedade Unipessoal, Ltda, 15 Defensores de Chaves Avenue, Lisboa, Portugal to Instradent AG, Peter Merian-Weg 12 4052, Basel, Switzerland 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.
Certificate History Date Reference Number Action 05 August 2016 8586494 Certificate Renewal Removal of dental implants from the scope Addition of crucial suppliers: ACNIS Do 9 Rua Ecydir Vieira Soares - 13, JD Amalia / Sorocaba -SP), Dynamet, Incorporated 9195 Museum Road, Washington, PA 15301, Estados Unidos), Fort Wayne Metals Research Products Corporate (9609 Ardmore Avenue Fort Wayne, Indiana 46809, USA), Titanium Industries, Inc (18 Green Pond Road, Rockaway, NJ 07866, USA), Aços Böhler Uddeholm do, (Estr. Yae Massumoto, 353-09842-160 São Bernardo do Campo - SP ), Mesa Di Sala Giacomo & C. S.N.C (VIA DELL'ARTIGIANATO 35/37/39 25039 TRAVAGLIATO (BS) ITALY), Ivoclar Vivadent (RUA GERALDO FLAUSINO GOMES, 78 Bairro: BROOKLIN NOVO Cidade: SÃO PAULO Estado: SP CEP: 04575.060 ), Metoxit AG (Emdwiesenstrasse 6, 8240 Thayngen), Sandinox (Rua Pedro Almeida Lima, 700 - Eden - 18103-040 - Sorocaba SP), The Perrymann (213 Vandale Drive, Houston, PA 15342 USA). 18 November 2016 8638304 Scope extension to include sterile dental implants 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.