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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="Jason D" data-source="post: 296386" data-attributes="member: 12217"><p>First off you need to understand fda terminology.</p><p>“Fda approved” relates to drugs and class 3 items.</p><p>Therefore the fda does not “approve” dental restorative devices (abutments)</p><p></p><p>The fda “clears” things like abutment platform and connections as being substantially similar to other devices and meeting the descriptions of design provided. The fda does NOT evaluate the effectiveness of those materials and processes, simply that the documentation reflects the product or process accurately.</p><p></p><p>(Effectiveness testing as in the pharmaceutical industry include clinical trials etc. a new abutment platform is not subjected to such conditions.)</p><p></p><p>An enterprise must be “FDA Compliant” to produce abutments, using 510k cleared materials. </p><p>The compliance and documentation and materials tracking required are covered in cfr 820.</p></blockquote><p></p>
[QUOTE="Jason D, post: 296386, member: 12217"] First off you need to understand fda terminology. “Fda approved” relates to drugs and class 3 items. Therefore the fda does not “approve” dental restorative devices (abutments) The fda “clears” things like abutment platform and connections as being substantially similar to other devices and meeting the descriptions of design provided. The fda does NOT evaluate the effectiveness of those materials and processes, simply that the documentation reflects the product or process accurately. (Effectiveness testing as in the pharmaceutical industry include clinical trials etc. a new abutment platform is not subjected to such conditions.) An enterprise must be “FDA Compliant” to produce abutments, using 510k cleared materials. The compliance and documentation and materials tracking required are covered in cfr 820. [/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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