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U.S. FDA Medical Device Preformed Clasp 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 Clasp companies with:

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