VITA medical devices Certificates CE marking

Transcription

1 VITA medical devices Certificates CE marking VITA Zahnfabrik H. Rauter GmbH & Co. KG. Postfach D Bad Säckingen Tel. +49 (0) Fax +49 (0)

2 CE marking on VITA medical devices The enclosed product group overviews show which of our medical devices have the marking (identification number used by notified body). These are Class IIa medical devices. The CE marking on Class I medical devices is the sole responsibility of the manufacturer, therefore there is no notified body identification number after the CE. Depending on the risk they pose, medical devices are divided into one of four classes I, IIa, IIb und III. Our notified body, DEKRA Certification, issued the following certificates: 1. Certificate of quality assurance in compliance with EN ISO 9001 / and EN ISO / Certificate confirming that the quality assurance system complies with Appendix II, Section 3 of Council Directive 93/42/EWG of June 14, 1993 on medical devices By CE marking our products, we the manufacturer are certifying that they conform entirely to legal requirements. A conformity assessment procedure is used to check that all requirements have been met. All VITA products not listed in the overview are auxiliary materials (brushes, interspace varnish, etc.), which never have a CE marking.

3 What does the CE marking signify? CE signifies that a product conforms to European laws, meaning it meets all the legal requirements of such a product. CE signifies that a product conforms to European laws, meaning it meets all the legal requirements of such a product. To comply with Council Directive 93/42/EWG and the Medizinproduktegesetz (German medical devices law which implements the Directive), the manufacturer must present to the notified body product documentation proving that all the essential requirements pertaining to the sale and use of the products have been met. The essential requirements are: Manufacture of product in such a way to ensure that it is safe High degree of technical safety ensured by meeting chemical and physical requirements (e.g. manufacture according to ISO standards) Risk management (risk/ benefit analysis, conformity to standards, continuous assessment) Biocompatibility Clinical assessment Continuous monitoring of marketed goods (reporting of incidents, safety plan) By CE marking its products, the manufacturer certifies that they conform entirely to legal requirements, thus enabling the free movement of goods on the EU internal market. At the same time, the CE marking reduces the amount of necessary documents and certificates to the absolute minimum. At the same time, the CE marking reduces the amount of necessary documents and certificates to the absolute minimum. From a legal point of view, a dental laboratory is a manufacturer of custommade medical devices. Although its quality management system does not by law have to be certified according to EN ISO 9001 and EN ISO 13485, it must provide documentation for every custom-made device (metal, metal ceramic, all-ceramic and acrylic crowns, bridges, inlays, etc.) stipulating All materials used (e.g. alloys, dental ceramic materials) All manufacturing stages and processes (see Appendices I and VIII of Council Directive 93/42/ EWG) The simplest way of proving that the essential requirements (see Appendix I of Directive 93/42/EWG) pertaining to the dental restoration have been met is to use medical devices with a CE marking.

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7 Overview of medical devices VITA all-ceramics VITA In-Ceram VITABLOCS VITA machinable polymers Clinical products VITA In-Ceram slip technique VITA In-Ceram MC material VITA In-Ceram accessories VITABLOCS Mark II Vitablocs accessories VITA In-Ceram SPINELL VITA In-Ceram SPINELL Coloring Liquid VITABLOCS ESTHETIC LINE CERECPropellant, powder + piquid (CE) VITA CAD-Waxx VITA Luting Set (Coltene CE 0123 and CE 0124) VITA In-Ceram ALUMINA VITA In-Ceram ALUMINA VITABLOCS TriLuxe VITA Ceramics Etch VITA In-Ceram ZIRCONIA VITA In-Ceram ZIRCONIA VITA Etchant Gel (Coltene CE 0123) VITA teeth VITA equipment VITA In-Ceram YZ Oxyprevent VITA In-Ceram AL Acrylic teeth Ceramic teeth Teeth accessories VITA vacuum equipment VITA atmospheric equipment Shade determination VITA A.R.T. Bond (Coltene CE 0123) VITAPAN VITA LUMIN VACUUM VITACOLL bonding agent VITA VACUMAT 4000 PREMIUM T VITA ZYrcomat VITA Easyshade (CE) VITA Duo Cement (Coltene CE 0123) VITA PHYSIODENS VITAFOL H silicone insulating film VITA VACUMAT 40 T VITA ATMOMAT Toothguide Vitasil VITA TRIOSTAT Impression trays (CE) VITA INCERAMAT 3T VITA DUOSTAT VITA SICCOTHERM VITA LUMIN ACRYL V VITASONIC Veneering materials Metal ceramics All-ceramics Ceramic accessories Veneering acrylics Veneering acrylic accessories VITA OMEGA 900 VITA RESPONSE VITA VM 7 Ceramic stains (Akzent, Interno, shading Paste) VITA METALL CORRECTOR SET VITA VM LC (CE0124) VITA ZETA LC COMPOSITE Modeling liquids VITA OMEGA VITA TITANKERAMIK VITA VM 9 VITA SPRAY-ON D-MASTER Modeling liquids VITA VM BOND (CE0124) VITA ZETA CC POLYMER VITA VMK 95 VITA VM 13 VITADUR ALPHA VITA Modisol VITA ZETA HC COMPOSITE VITA ZETA HLC BOND

8 VITA Zahnfabrik H. Rauter GmbH & Co. KG. Postfach D Bad Säckingen Tel. +49 (0) Fax +49 (0) D (1.) Si