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U.S. FDA Medical Device Amalgam Alloy Requirements: Amalgam Alloy

FDA Medical Device Definition: An amalgam alloy is a device that consists of a metallic substance intended to be mixed with mercury to form filling material for treatment of dental caries

Registrar Corp assists Amalgam Alloy companies with:

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