DAkkSDeutscheAkkreditierungsstelleD-ZM-11321-01-00

CertificateNo. Q5 020326 0059 Rev. 00

y TOYSDD

Product Service

Holder of Certificate:

Certification Mark:

Scope of Certificate:

Institut Straumann AGPeter Merian-Weg 124002 BaselSWITZERLAND

TOYSDD

tuv-sud.comfps-cert

Design and Development, Production andDistribution of Implants, Dental Materials,Prosthetic Components, Invasive andNon-lnvasive Instruments, Auxiliary Components,Cassettes (Product and Product Related Services)for use in Oral and Extraoral Implantology(Maxillo-Facial Surgery) and Dental ProstheticRestoration(see page 2 for additional locations)

The Certification Body of TOV SOD Product Service GmbH certifies that the company mentionedabove has established and is maintaining a quality management system, which meets therequirements of the listed standard(s). See also notes overleaf.

Report No.: 713132055

Valid from:Valid until:

2018-10-232021-10-22

Date, 2018-10-23Stefan PreiB

Page 1 of 2TOV SOD Product Service GmbH • Certification Body • RidlerstraBe 65 • 80339 Munich • Germany TUVy

DAkkSDeutscheAkkreditierungsstelleD-ZM-11321-01-00

TOYSDD

Product Service

CertificateNo. Q5 020326 0059 Rev. 00

Applied Standard(s): EN ISO 13485:2016Medical devices - Quality management systems -Requirements for regulatory purposes(13013485:2016)DIN EN ISO 13485:2016

Facility(ies): Institut Straumann AGPeter Merian-Weg 12, 4002 Basel, SWITZERLAND

Institut Straumann AGGartenstrasse 143, 4002 Basel, SWITZERLAND

Etkon GmbHRiquetstrasse 8 & Koburger Strasse 45, 04416 Markkleeberg, GERMANY

Straumann Villeret SALes Champs du dos 2, 2613 Villeret, SWITZERLAND

Straumann Manufacturing Inc60 Minuteman Road, Andover MA 01810, USA

Straumann Villeret SAGrand Rue 53 a, 2606 Corgemont, SWITZERLAND

Parameters:./.

Page 2 of 2TOV SOD Product Service GmbH • Certification Body • RidlerstraBe 65 • 80339 Munich • Germany -ruv"