JMN
Christian Member
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FDA and DAMAS/ISO are very different things. If it is FDA 510(k) certified it is legal to sell in the USA. Having a different standard in what you sell, as long as the legal and moral obligations are met is not wrong, just different. As you said, you are welcome to yours and everyone else to theirs.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.
However, if that additional layer of certification given by ISO/DAMAS to the place and process making your restoration is what you want, that's fine too.
Just be willing to pay extra for it.