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U.S. FDA Medical Device Noble Metal Alloy Requirements

FDA Medical Device Definition: A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.

Registrar Corp assists Noble Metal Alloy companies with:

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