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U.S. FDA Medical Device Gold-Based 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 Gold-Based Noble Metal Alloy companies with:

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