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U.S. FDA Medical Device Preformed Anchor Requirements

FDA Medical Device Definition: A preformed anchor is a device made of austenitic alloys or alloys containing 75 percent or greater gold or metals of the platinum group intended to be incorporated into a dental appliance, such as a denture, to help stabilize the appliance in the patient's mouth.

Registrar Corp assists Preformed Anchor companies with:

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