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U.S. FDA Medical Device Preformed Cusp Requirements

FDA Medical Device Definition: A performed cusp is a prefabricated device made of plastic or austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be used as a temporary cusp (a projection on the chewing surface of a tooth) to achieve occlusal harmony (a proper bite) before permanent restoration of a tooth.

Registrar Corp assists Preformed Cusp companies with:

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