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Implants
FDA 510K Implant abutment clearance
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<blockquote data-quote="keith goldstein" data-source="post: 211178" data-attributes="member: 11350"><p>I believe you are correct regarding Biodenta. They also offer an implant too. This is going to be one of the futures- labs selling implants along with everything else, including small labs since the loyalty of the implant companies will largely be for a select few labs. </p><p></p><p>Linda thanks for the clarification - I spoke to one of their competitors regarding this "fda approved" system which would be just like Cerec and this vendor who sells through distributors said they would have their distributors go through FDA on the entire system. 3Shape absolutely could do this just takes money and time and maybe they will be forced to because of FDA requirements...lets hope not since this would not be good for any of the open architecture cad/cam suppliers and especially the small and medium size labs.</p></blockquote><p></p>
[QUOTE="keith goldstein, post: 211178, member: 11350"] I believe you are correct regarding Biodenta. They also offer an implant too. This is going to be one of the futures- labs selling implants along with everything else, including small labs since the loyalty of the implant companies will largely be for a select few labs. Linda thanks for the clarification - I spoke to one of their competitors regarding this "fda approved" system which would be just like Cerec and this vendor who sells through distributors said they would have their distributors go through FDA on the entire system. 3Shape absolutely could do this just takes money and time and maybe they will be forced to because of FDA requirements...lets hope not since this would not be good for any of the open architecture cad/cam suppliers and especially the small and medium size labs. [/QUOTE]
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FDA 510K Implant abutment clearance
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