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U.S. FDA Medical Device Base Metal Alloy Requirements

FDA Medical Device Definition: A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.

Registrar Corp assists Base Metal Alloy companies with:

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