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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: 294688" data-attributes="member: 1244"><p>Nothing at all on that page either with specific regulatory language that might indicate that model printers need a certain certification. I even read through the entire list of medical devices classified by the FDA under CFR 21, Part 872, subparts A-G (two more clicks) and found no mention of dental models or model printers.</p><p></p><p>I find your original statement: "...you will need to ensure the hardware you use to print MODELS (if you print models) has class 2 certification for medical devices..." difficult to believe.</p></blockquote><p></p>
[QUOTE="JayH, post: 294688, member: 1244"] Nothing at all on that page either with specific regulatory language that might indicate that model printers need a certain certification. I even read through the entire list of medical devices classified by the FDA under CFR 21, Part 872, subparts A-G (two more clicks) and found no mention of dental models or model printers. I find your original statement: "...you will need to ensure the hardware you use to print MODELS (if you print models) has class 2 certification for medical devices..." difficult to believe. [/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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