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Is FDA Registration Required for Manufacturing Surgical Guides?

 Dental implant.jpg


FDA continues to require that manufacturers of certain dental products register with FDA. In some recent FDA inspections of dental labs it has been brought to their attention that the use of CAD/CAM technology in the manufacture of surgical guides for guided implant surgery requires FDA registration

FDA determines that dental surgical guides for dental implants manufactured with the use of CAD/CAM are regulated as Class I medical devices.  They are 510(k) exempt; however, they do require FDA registration and listing by the manufacturer. 

Here are some scenarios so you can determine if your business meets this requirement when manufacturing surgical guides for guided surgery:

  • Dentist sends CT scan to the dental lab, lab designs, has doctor approve, then lab manufactures the surgical guide using CAD/CAM technology: Lab must register and list.
  • Dentist sends CT scan to the dental lab, lab designs, has doctor approve, then sends to another company for manufacture: Lab does not have to register and list.

If you attempt to do dental surgical guide FDA registration on your own, then use the listing code of NDP.

Contact us if you need assistance with:

  • dental surgical guide FDA registration requirements
  • other FDA dental regulations
  • attaining FDA 510k consultants / 510 consultants

SafeLink Consulting’s FDA compliance consultants can provide assistance in determining if your business model meets 510(k) requirement, FDA 510k submission, plus guidance on FDA registration, quality system consulting, and implementation of current good manufacturing practices - gmp for medical devices manufacturers including the dental lab, plus beverage manufacturers to ensure that your business is doing the best it can to provide products that are both healthy and safe for the public.

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