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Lab talk, the good, the bad, and the ugly
3D Printer
3D Dental Printer vs. 3D Printers
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<blockquote data-quote="JayH" data-source="post: 294673" data-attributes="member: 1244"><p>The only statement on either of those two pages that I could find that comes close to what I perceived you were saying is:</p><p></p><p>"In 2017, the FDA announced that software intended to create output files for 3D printing patient-specific anatomical models, which are used for diagnostic purposes, is considered a class II medical device and requires regulatory clearance." And that was basically an ad for Materialise / Stratasys.</p><p></p><p>Got any link to specific regulatory language, on a regulatory body's web site, that might indicate that model printers need a certain certification?</p></blockquote><p></p>
[QUOTE="JayH, post: 294673, member: 1244"] The only statement on either of those two pages that I could find that comes close to what I perceived you were saying is: "In 2017, the FDA announced that software intended to create output files for 3D printing patient-specific anatomical models, which are used for diagnostic purposes, is considered a class II medical device and requires regulatory clearance." And that was basically an ad for Materialise / Stratasys. Got any link to specific regulatory language, on a regulatory body's web site, that might indicate that model printers need a certain certification? [/QUOTE]
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Lab talk, the good, the bad, and the ugly
3D Printer
3D Dental Printer vs. 3D Printers
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