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U.S. FDA Medical Device Dental Operating Light Requirements


FDA Medical Device Definition: A dental operating light, including the surgical headlight, is an AC-powered device intended to illuminate oral structures and operating areas.

Registrar Corp assists Dental Operating Light companies with:

  • FDA Dental Operating Light Establishment Registration
  • FDA Dental Operating Light Listing
  • FDA Dental Operating Light Label Requirements and Exceptions
  • FDA Dental Operating Light Import Information
  • FDA Dental Operating Light Detentions (Dental Operating Light Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Dental Operating Light Manufacturers (Dental Operating Light Suppliers)
       - Dental Operating Light Distributors
       - Dental Operating Light Processors
       - Dental Operating Light Repackers
       - Dental Operating Light Relabelers
       - Dental Operating Light Exporters
       - Dental Operating Light Importers
For more information about Dental Operating Light Medical Devices, simply click below:






 
U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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