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Implants
FDA 510K Implant abutment clearance
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<blockquote data-quote="Beatrice" data-source="post: 201157" data-attributes="member: 1017"><p>You are correct, BUT</p><p>Only 1 company offer approved block at the moment.</p><p></p><p>Otherwise you can outsource your abutment to milling center that mill the interface and are approved by the FDA. </p><p>And there are few.</p><p></p><p>Right now if FDA apply what they say we are talking over +/-90% of abutment milling center that would have to stop production until they get their FDA approval.</p></blockquote><p></p>
[QUOTE="Beatrice, post: 201157, member: 1017"] You are correct, BUT Only 1 company offer approved block at the moment. Otherwise you can outsource your abutment to milling center that mill the interface and are approved by the FDA. And there are few. Right now if FDA apply what they say we are talking over +/-90% of abutment milling center that would have to stop production until they get their FDA approval. [/QUOTE]
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FDA 510K Implant abutment clearance
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