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Dentallabnetwork.com
Outsourcing Concerns- FDA Regulations-ADA Regulati
List of FDA approved custom milled ti abutment blank/mill combo
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<blockquote data-quote="keith goldstein" data-source="post: 310327" data-attributes="member: 11350"><p>This never changed. It does not matter if you are a dentist or a dental lab using a stock abutment or making any custom abutment the same rules have always applied (since the FDA began requiring that all implant abutments are FDA registered 25+ years ago) the part (implant connection and screw) have to be FDA registered/approved. The dentist do not have any special rights. It raises a number of concerns when a part is not approved since it means there is no testing done on it's long term fit and tolerance of the connection and the screw.</p></blockquote><p></p>
[QUOTE="keith goldstein, post: 310327, member: 11350"] This never changed. It does not matter if you are a dentist or a dental lab using a stock abutment or making any custom abutment the same rules have always applied (since the FDA began requiring that all implant abutments are FDA registered 25+ years ago) the part (implant connection and screw) have to be FDA registered/approved. The dentist do not have any special rights. It raises a number of concerns when a part is not approved since it means there is no testing done on it's long term fit and tolerance of the connection and the screw. [/QUOTE]
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Outsourcing Concerns- FDA Regulations-ADA Regulati
List of FDA approved custom milled ti abutment blank/mill combo
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