EC Design Examination Certificate Council Directive 93/42/EEC Annex II Section 4 This is to certify that the manufacturer FMZ GmbH Charles Darwin Ring 3a 18059 Rostock Germany that the design of the following device(s) alphatech® dental implants sterile Tube-Line VTPS-BONIT® Tube-Line-BONITex® Uni-Line-VTPS-BONIT® Slim-Line® BONITex® is conform to the Essential Requirements of Annex I of the Council Directive 93/42/EEC concerning medical devices. This EC Design Examination Certificate is only valid in connection with the valid DQS Medizinprodukte GmbH Certificate No. 204456 MR2. Changes to the approved design are subject to further approval by the Notified Body. Basis of examination: alphatech® Technische Dokumentation Implantate Klasse IIb/III Rev.6 dated 2019-04-24 Further basis for the examination is referenced in the examination report and relating documents mentioned below. Examination report: 411_18d_Produktauslegungspruefung alphatech 102019 rev01.docx dated 2019-11-18 The results of the examination are contained in the above mentioned report and the relating documents mentioned within. Effective date Expiry date Dr. Thomas Feldmann Head of Certification Body August-Schanz-Straße 21, 60433 Frankfurt am Main, Tel. +49 (0) 69 95427-300, [email protected] DQS Medizinprodukte GmbH is a Notified Body according to Council Directive 93/42/EEC concerning medical devices with the Identification Number 0297. Sigrid Uhlemann Managing Dir