Engelsk titel: Overseas and Norwegian made dental crowns - does the delivery meet the ordered
specifications?
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Författare:
Syverud, Morten
;
Austrheim, Ellen Kristine
Email: morten.syverud@niom.no
Språk: Nor
Antal referenser: 14
Dokumenttyp:
Artikel
UI-nummer: 15013046
Sammanfattning
Twenty-four dental crowns made overseas and 18 crowns made in Norway have been
investigated for fulfilment of the requirements according to the Medical Devices Directive
(93/42/EEC). The compliance between ordered and delivered alloy composition, content of the toxic
elements Ni, Cd and Be, and stated declaration of conformity with the Medical Devices Directive were
investigated. The investigation revealed major deficiencies for both imported and Norwegian-made
crowns regarding conformity between composition and the stated declaration. The deviation in the
composition was especially pronounced for the imported crowns. Toxic elements were found in
neither imported nor Norwegian-made crowns.