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Lab talk, the good, the bad, and the ugly
3D Printer
I want a 3D printer mainly for surgical guides, please suggest one
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<blockquote data-quote="Foggy_in_RI" data-source="post: 356052" data-attributes="member: 23810"><p>From: <a href="https://www.aegisdentalnetwork.com/idt/2020/02/fda-expands-laboratory-requirements" target="_blank">https://www.aegisdentalnetwork.com/idt/2020/02/fda-expands-laboratory-requirements</a></p><p></p><h2>Accessories: Implant, Dental, Endosseous</h2><p>This product classification includes surgical guides for dental implants and this modification will definitely have an impact on printed or milled surgical guides. The FDA added a note to the product classification to the Product Code NDP2stating that a dental laboratory or a surgical guide service provider must "register their establishment" and operate under a Quality Management System. This is the modification that occurred without "written guidance" for the industry to prepare for the change. <strong>In communications, the FDA Division of Industry and Consumer Education (DICE) specifically directed the author that the manufacturer of a CAD/CAM Class 1 dental implant surgical guide would be regulated as a device manufacturer and required to comply with the FDA requirements, including having to register their establishment, listing their product,3 and needing to follow the Quality System (QS) regulation.</strong></p></blockquote><p></p>
[QUOTE="Foggy_in_RI, post: 356052, member: 23810"] From: [URL]https://www.aegisdentalnetwork.com/idt/2020/02/fda-expands-laboratory-requirements[/URL] [HEADING=1]Accessories: Implant, Dental, Endosseous[/HEADING] This product classification includes surgical guides for dental implants and this modification will definitely have an impact on printed or milled surgical guides. The FDA added a note to the product classification to the Product Code NDP2stating that a dental laboratory or a surgical guide service provider must "register their establishment" and operate under a Quality Management System. This is the modification that occurred without "written guidance" for the industry to prepare for the change. [B]In communications, the FDA Division of Industry and Consumer Education (DICE) specifically directed the author that the manufacturer of a CAD/CAM Class 1 dental implant surgical guide would be regulated as a device manufacturer and required to comply with the FDA requirements, including having to register their establishment, listing their product,3 and needing to follow the Quality System (QS) regulation.[/B] [/QUOTE]
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Lab talk, the good, the bad, and the ugly
3D Printer
I want a 3D printer mainly for surgical guides, please suggest one
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