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Implants
FDA 510K Implant abutment clearance
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<blockquote data-quote="Zubler USA" data-source="post: 201079" data-attributes="member: 6881"><p>Not so sure, Let me predicate this by saying, I may be incorrect in my interpretation. Which is why it is so important for you to do your own homework. But it seems FDA compliance in the form of traceable process control, may extend beyond the interface. Either way, you are definitely better off using a per-approved implant/interface system, but FDA approval may still need to be obtained on an individual basis at the laboratory level provng you have controls in place that guarantee safety and quality.</p></blockquote><p></p>
[QUOTE="Zubler USA, post: 201079, member: 6881"] Not so sure, Let me predicate this by saying, I may be incorrect in my interpretation. Which is why it is so important for you to do your own homework. But it seems FDA compliance in the form of traceable process control, may extend beyond the interface. Either way, you are definitely better off using a per-approved implant/interface system, but FDA approval may still need to be obtained on an individual basis at the laboratory level provng you have controls in place that guarantee safety and quality. [/QUOTE]
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FDA 510K Implant abutment clearance
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