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Implants
FDA 510K Implant abutment clearance
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<blockquote data-quote="brayks" data-source="post: 198038" data-attributes="member: 11275"><p>My understanding is that the labs, milling centers, etc. are NOT required to obtain these clearances IF they utilize pre-form blanks who have the proper FDA clearances. Such clearances are now rumored (since I am not aware of any published FDA statements clarifying the matter) to include FDA cleared work instructions that are verified to include the use of stated CAD or CAM software with "hard-stops" that occur when a CAD or CAM software processes a custom abutment case with their pre-form blank that falls outside of the safe usage parameters of a given manufacturers implant platform.</p><p></p><p>I have spoken to very many consultants and quickly learned that although there are very good ones; very many consultants are like excuses... One really has to vent them properly to make sure you do get a good one.</p><p></p><p>Just my couple of cents...</p></blockquote><p></p>
[QUOTE="brayks, post: 198038, member: 11275"] My understanding is that the labs, milling centers, etc. are NOT required to obtain these clearances IF they utilize pre-form blanks who have the proper FDA clearances. Such clearances are now rumored (since I am not aware of any published FDA statements clarifying the matter) to include FDA cleared work instructions that are verified to include the use of stated CAD or CAM software with "hard-stops" that occur when a CAD or CAM software processes a custom abutment case with their pre-form blank that falls outside of the safe usage parameters of a given manufacturers implant platform. I have spoken to very many consultants and quickly learned that although there are very good ones; very many consultants are like excuses... One really has to vent them properly to make sure you do get a good one. Just my couple of cents... [/QUOTE]
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FDA 510K Implant abutment clearance
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