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<blockquote data-quote="Periodent" data-source="post: 255955" data-attributes="member: 18944"><p>Based on your statement I conclude that you are not a Lab owner. If I buy a car than I do this for my personal needs and pleasure and do of course my diligence too.</p><p></p><p>When I sell crowns, bridges, bars, etc. to my customers then I am responsible for those dental restorations that are considered medical devices and therefore must meet U.S. Food and Drug Administration requirements. This includes registration of establishment, listing of devices, 510(k) approval, etc. If CMC can certify the manufacturing process of their products then it would be less concern. Until now CMC is neither ISO nor DAMAS certified.</p><p></p><p></p><p>Ultimately, it’s up to you where you outsource your bar or restorations.</p></blockquote><p></p>
[QUOTE="Periodent, post: 255955, member: 18944"] Based on your statement I conclude that you are not a Lab owner. If I buy a car than I do this for my personal needs and pleasure and do of course my diligence too. When I sell crowns, bridges, bars, etc. to my customers then I am responsible for those dental restorations that are considered medical devices and therefore must meet U.S. Food and Drug Administration requirements. This includes registration of establishment, listing of devices, 510(k) approval, etc. If CMC can certify the manufacturing process of their products then it would be less concern. Until now CMC is neither ISO nor DAMAS certified. Ultimately, it’s up to you where you outsource your bar or restorations. [/QUOTE]
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