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Lab talk, the good, the bad, and the ugly
3D Printer
Got an email re: Asiga or nextdent.
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<blockquote data-quote="LarryRDC" data-source="post: 293875" data-attributes="member: 11609"><p>cadfan, I think you may be correct. The 510k thing in the US can be certainly be complicated and confusing ( at least to me...) The way I understand it is, everything is approved to work together...equipment + materials + processing. Once you add or subtract anything from that system that is not approved (such as different materials or equipment ) you are technically no longer in compliance. If want to do it another way, then you have pay up and go through the whole "spiel" to become compliant. $$<img src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" class="smilie smilie--sprite smilie--sprite12" alt="o_O" title="Er... what? o_O" loading="lazy" data-shortname="o_O" /></p></blockquote><p></p>
[QUOTE="LarryRDC, post: 293875, member: 11609"] cadfan, I think you may be correct. The 510k thing in the US can be certainly be complicated and confusing ( at least to me...) The way I understand it is, everything is approved to work together...equipment + materials + processing. Once you add or subtract anything from that system that is not approved (such as different materials or equipment ) you are technically no longer in compliance. If want to do it another way, then you have pay up and go through the whole "spiel" to become compliant. $$o_O [/QUOTE]
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Lab talk, the good, the bad, and the ugly
3D Printer
Got an email re: Asiga or nextdent.
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