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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="CoolHandLuke" data-source="post: 310447" data-attributes="member: 4850"><p>Doctors were not supposed under the fda to manufacture their own restorations, which is why theres no regulation. </p><p></p><p>In order to obtain a proper long term 510k clearance you will need to show how consistent your abutments are, and how substantially similar your abutments are in relation to the original manufacturing geometry.</p><p></p><p>There are also clearances required for your cad software and cam software. </p><p></p><p>Ref <a href="https://www.aegisdentalnetwork.com/id/2015/06/non-fda-compliant-ti-cadcam-custom-abutments" target="_blank">https://www.aegisdentalnetwork.com/id/2015/06/non-fda-compliant-ti-cadcam-custom-abutments</a></p><p> The FDA regulates CAD/CAM technologies in the dental laboratory under the <a href="https://evo820.com/our-services/fda-21-cfr-part-820/" target="_blank">FDA’s Title 21 CFR 820,</a> which providesa framework for Current Good Manufacturing Practices (CGMP),and quality management procedures used in the manufacturing of Class II medical devices</p><p></p><p>Per <a href="http://www.dentalproductsreport.com/lab/article/increasing-fda-involvement-cadcam-dental-restorations" target="_blank">http://www.dentalproductsreport.com/lab/article/increasing-fda-involvement-cadcam-dental-restorations</a></p><p></p><p>An article written by tim.</p></blockquote><p></p>
[QUOTE="CoolHandLuke, post: 310447, member: 4850"] Doctors were not supposed under the fda to manufacture their own restorations, which is why theres no regulation. In order to obtain a proper long term 510k clearance you will need to show how consistent your abutments are, and how substantially similar your abutments are in relation to the original manufacturing geometry. There are also clearances required for your cad software and cam software. Ref [URL]https://www.aegisdentalnetwork.com/id/2015/06/non-fda-compliant-ti-cadcam-custom-abutments[/URL] The FDA regulates CAD/CAM technologies in the dental laboratory under the [URL='https://evo820.com/our-services/fda-21-cfr-part-820/']FDA’s Title 21 CFR 820,[/URL] which providesa framework for Current Good Manufacturing Practices (CGMP),and quality management procedures used in the manufacturing of Class II medical devices Per [URL]http://www.dentalproductsreport.com/lab/article/increasing-fda-involvement-cadcam-dental-restorations[/URL] An article written by tim. [/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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