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Implants
FDA 510K Implant abutment clearance
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<blockquote data-quote="Zubler USA" data-source="post: 201056" data-attributes="member: 6881"><p>This topic got brought up again for me recently so I did some research and have seen many of the same posts mentioned on this forum. I also ventured over to the FDA website and started reading...a lot! Anyone done that yet? I also re-read the posts from the different industry groups after going to the FDA website. Once re-read, light was shed on many of their interpretations. Ultimately, none of you are going to get accurate detail without speaking directly to the FDA or an attorney you can trust. But ultimately, I came to the conclusion that laboratories are going to have to get FDA clearance to use CAD/CAM machines to mill abutments from the collar down. Ironically you can still cast or Hand mill without FDA clearance. What is unclear are the requirements needed from the manufacturers. If you believe what was posted on some of the websites, those of you that have already invested in machines are going to have to hope and wait for your manufactures to comply before you can. However, I am not sure this is the case. More will come out soon. Manufacturers are all probably swarming the FDA right now. Chicago will be all about this. Go if you can.</p></blockquote><p></p>
[QUOTE="Zubler USA, post: 201056, member: 6881"] This topic got brought up again for me recently so I did some research and have seen many of the same posts mentioned on this forum. I also ventured over to the FDA website and started reading...a lot! Anyone done that yet? I also re-read the posts from the different industry groups after going to the FDA website. Once re-read, light was shed on many of their interpretations. Ultimately, none of you are going to get accurate detail without speaking directly to the FDA or an attorney you can trust. But ultimately, I came to the conclusion that laboratories are going to have to get FDA clearance to use CAD/CAM machines to mill abutments from the collar down. Ironically you can still cast or Hand mill without FDA clearance. What is unclear are the requirements needed from the manufacturers. If you believe what was posted on some of the websites, those of you that have already invested in machines are going to have to hope and wait for your manufactures to comply before you can. However, I am not sure this is the case. More will come out soon. Manufacturers are all probably swarming the FDA right now. Chicago will be all about this. Go if you can. [/QUOTE]
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