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Implants
Making abutments non-engaging
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<blockquote data-quote="npdynamite" data-source="post: 342542" data-attributes="member: 11802"><p>In most labs this is the impression I've gotten, it's just with the amount of changes in regulation regarding custom Ti abutments and what it takes for a lab to be able to mill an interface, it just seems like this should fall into the same type of regulation.</p><p></p><p>At the same time I've had recent conversations with a Dr. who has suggested that because he is a doctor that he doesn't need the FDA clearance to mill an interface that a lab would need. It doesn't make any sense to me that a doctor should be able to circumvent a regulation to control the quality of manufacturing medical parts because the matter at hand has absolutely nothing to do with a doctors education, it has to do with engineering and manufacturing. Why would a doctor be more qualified to say if a custom milled/modified part is "good enough"? That's getting into a slightly different subject but still along the same lines.</p><p></p><p>The other question all this brings up is, why does the FDA even matter to labs if we can supposedly circumvent their regulation as long as the doctor is in the loop and ok with it? Because if this modification is ok with a doctors permission but not ok without, isn't that what is implied? So say for example if a lab worked up their entire own implant library and bought Ti pucks and started milling their own custom abutments and various interfaces but didn't get any of this approved through the FDA. If they went to their doctors they could just explain what they were doing and if the doctor was cool with it they could just proceed? This seems highly unlikely to me.</p></blockquote><p></p>
[QUOTE="npdynamite, post: 342542, member: 11802"] In most labs this is the impression I've gotten, it's just with the amount of changes in regulation regarding custom Ti abutments and what it takes for a lab to be able to mill an interface, it just seems like this should fall into the same type of regulation. At the same time I've had recent conversations with a Dr. who has suggested that because he is a doctor that he doesn't need the FDA clearance to mill an interface that a lab would need. It doesn't make any sense to me that a doctor should be able to circumvent a regulation to control the quality of manufacturing medical parts because the matter at hand has absolutely nothing to do with a doctors education, it has to do with engineering and manufacturing. Why would a doctor be more qualified to say if a custom milled/modified part is "good enough"? That's getting into a slightly different subject but still along the same lines. The other question all this brings up is, why does the FDA even matter to labs if we can supposedly circumvent their regulation as long as the doctor is in the loop and ok with it? Because if this modification is ok with a doctors permission but not ok without, isn't that what is implied? So say for example if a lab worked up their entire own implant library and bought Ti pucks and started milling their own custom abutments and various interfaces but didn't get any of this approved through the FDA. If they went to their doctors they could just explain what they were doing and if the doctor was cool with it they could just proceed? This seems highly unlikely to me. [/QUOTE]
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Making abutments non-engaging
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