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U.S. FDA Medical Device Dental Mercury Requirements: Dental Mercury

FDA Medical Device Definition: Dental mercury is a device composed of mercury intended for use as a component of amalgam alloy in the restoration of a dental cavity or a broken tooth

Registrar Corp assists Dental Mercury companies with:

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

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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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