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Dentallabnetwork.com
Outsourcing Concerns- FDA Regulations-ADA Regulati
List of FDA approved custom milled ti abutment blank/mill combo
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<blockquote data-quote="DrG" data-source="post: 296388" data-attributes="member: 19668"><p>Thank you Jason for the above information.</p><p>If a Ti blank is to be milled into a Ti abutment, the blank needs to be 510k cleared, I get it. Does FDA has any red tape/regulation on the millling machine and CAD/CAM software to produce a product that is safe and at least as good as the standard equivalent it is being compared to ?</p><p>I suppose the answer to my question lies in that the enterprise must be FDA compliant and documents it with cfr820, correct ?</p></blockquote><p></p>
[QUOTE="DrG, post: 296388, member: 19668"] Thank you Jason for the above information. If a Ti blank is to be milled into a Ti abutment, the blank needs to be 510k cleared, I get it. Does FDA has any red tape/regulation on the millling machine and CAD/CAM software to produce a product that is safe and at least as good as the standard equivalent it is being compared to ? I suppose the answer to my question lies in that the enterprise must be FDA compliant and documents it with cfr820, correct ? [/QUOTE]
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Outsourcing Concerns- FDA Regulations-ADA Regulati
List of FDA approved custom milled ti abutment blank/mill combo
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