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U.S. FDA Medical Device Preformed Gold Denture Teeth Requirements


FDA Medical Device Definition: A preformed gold denture tooth is a device composed of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended for use as a tooth or a portion of a tooth in a fixed or removable partial denture.

Registrar Corp assists Preformed Gold Denture Teeth companies with:

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