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<blockquote data-quote="DESS-USA" data-source="post: 315137" data-attributes="member: 19445"><p>Darwin -</p><p>The supplier has to have FDA 510K for the part.</p><p>Regarding the lab there is no 510K/FDA that they can obtain.</p><p>They can have a quality management system in place that will be utilized during a FDA audit and they can reference the parts they are using as part of that QMS but with these measures in place they are not provided with a 510K number, etc.</p><p></p><p>However when it comes to utilizing tibases or milling custom titanium abutments using premills in the lab the supplier/manufacturer's 510K will state they (the lab) has the authority to do so because the lab is a validated milling center for manufacture. Please see this 510K under Indication for Use Statement -</p><p>[URL unfurl="true"]https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191986.pdf[/URL]</p><p></p><p>There are 510K's from other implant part manufacturers/distributors/resllers/milling centers which specifically state that they are the only one's who can use these parts in their facility and no one else. This is why all labs should be reading the 510K documents to ensure that the parts they are using have a 510K.</p><p></p><p>Thanks,</p><p>Keith</p></blockquote><p></p>
[QUOTE="DESS-USA, post: 315137, member: 19445"] Darwin - The supplier has to have FDA 510K for the part. Regarding the lab there is no 510K/FDA that they can obtain. They can have a quality management system in place that will be utilized during a FDA audit and they can reference the parts they are using as part of that QMS but with these measures in place they are not provided with a 510K number, etc. However when it comes to utilizing tibases or milling custom titanium abutments using premills in the lab the supplier/manufacturer's 510K will state they (the lab) has the authority to do so because the lab is a validated milling center for manufacture. Please see this 510K under Indication for Use Statement - [URL unfurl="true"]https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191986.pdf[/URL] There are 510K's from other implant part manufacturers/distributors/resllers/milling centers which specifically state that they are the only one's who can use these parts in their facility and no one else. This is why all labs should be reading the 510K documents to ensure that the parts they are using have a 510K. Thanks, Keith [/QUOTE]
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