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Implants
FDA 510K Implant abutment clearance
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<blockquote data-quote="Linda Saylor" data-source="post: 208462" data-attributes="member: 15071"><p>Unfortunately, those 510k's (couldn't find the first one) are either old or for use with Sirona which at this point is the only CAD/CAM software that is FDA approved otherwise you must become an FDA certified milling center. It is true what is being said. However it is not impossible to become a milling center; but it is a lot of work!!! Think ISO 13485 certified and harmonized with the FDA GMP and QS. What we need is for 3Shape and DentalWings to become FDA approved. That would solve a lot of problems.</p></blockquote><p></p>
[QUOTE="Linda Saylor, post: 208462, member: 15071"] Unfortunately, those 510k's (couldn't find the first one) are either old or for use with Sirona which at this point is the only CAD/CAM software that is FDA approved otherwise you must become an FDA certified milling center. It is true what is being said. However it is not impossible to become a milling center; but it is a lot of work!!! Think ISO 13485 certified and harmonized with the FDA GMP and QS. What we need is for 3Shape and DentalWings to become FDA approved. That would solve a lot of problems. [/QUOTE]
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