Full Quality Assurance System Approval Certificate On the basis of our examination carried out according to Annex II, excluding section 4, of the Directive 93/42/EEC and its revised version, we hereby certify that: IMPLANT PROTESIS DENTAL 2004, S.L. 08302 MATARÓ (BARCELONA) - CAMI DEL MIG 71 1° 2° (ESP) - Spain manages in the factory of: 08302 MATARÓ (BARCELONA) - CAMI DEL MIG 71 1° 2° (ESP) - Spain a quality assurance system ensuring the conformity of the following products: Dental abutment and prosthetic screw Type ref. as to document ‘Annex of EC Certificate no. 1975/MDD - Device List’ rev. 0 dated 2020/12/23; this annex is integral and substantial part of this certificate. with the relevant essential requirements of the aforementioned directive (from design to final inspection and testing) and it is subject to surveillance as specified in section 5 of Annex II. For class III devices, this certificate is valid only with the relevant EC Design-Examination Certificate of Annex II.4. Reference to IMQ files Nos: DM17-0016358-01; DM18-0023569-01; DM18-0030896-01; DM19-0042162-01; DM20-0056964-01. This Approval Certificate is issued by IMQ S.p.A. as Notified Body for the Directive 93/42/EEC and its revised version. Notified Body notified to European Commission under number: 0051. Date: Updated: Substitution Date: Expiry Date: This Approval Certificate is subjected to the provisions laid down in the “IMQ regulation for the certification of Medical Devices - CE Marking - Directive 93/42/EEC”. This is a translation of the Italian text, which prevails in case of doubts IMQ S.p.A. | I-20138 Milano |Via Quintiliano 43 |