Silverfil Dental Products


Silverfil Argentum CE - Certificate Certification on Production Quality Assurance System under Annex V of the Directive 93/42/EEC on Medical Devices received from TÜV Product Service of the TÜV Suddeutschland group. This certification carries the CE mark with identification no. 0123 United States FDA 510(k) Issued by the Food & Drug Administration (FDA) of the United States of America. Click here to download the PDF



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External Links

- www.tuv-sud.com

- www.fda.gov

Silverfildental Products' Quality Management System is certified by TÜV Product Service / TÜV Management Service / TÜV America Inc. of the TÜV Suddeutschland group, one of the world's largest and most stringent quality certification bodies.

ISO 9001: 2000 (No. 12 100 23518 TMS)

Certifies that Silverfildental Products has established and applies a Quality Management System for Production and Distribution of Silverfil Argentum for Dental Filling Applications according to the requirements of ISO 9001: 2000.

EN ISO 13485: 2003 (No. Q2N 04 05 53132 001)

Certifies that Silverfildental Products is certified to EN ISO 13485: 2003 for the Production and Distribution of Silverfil Argentum for Dental Filling Applications according to the applied standard(s) of Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes.

CE - Certificate (No. G2 04 05 54169 003)

Certifies that Silverfildental Products has implemented a quality assurance system for manufacture and final inspection of the respective products / product categories, according to Annex V, section 3 of the Directive 93/42/EEC on Medical Devices with the identification number "CE 0123".

ISO 13485: 2003 SCC Accredited (No. S 951 05 3333)

Certifies that Silverfildental Products is certified to ISO 13485: 2003 for the Design and Development, Production and Distribution of Silverfil Argentum for Dental Filling Applications, accredited by the Standards Council of Canada (SCC) and a CMDCAS Recognised Registrar.