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U.S. FDA Medical Device Preformed Crown Requirements

FDA Medical Device Definition: A preformed crown 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 affixed temporarily to a tooth after removal of, or breakage of, the natural crown (that portion of the tooth that normally protrudes above the gums). It is intended for use as a functional restoration until a permanent crown is constructed. The device also may be intended for use as a functional restoration for a badly decayed deciduous (baby) tooth until the adult tooth erupts.

Registrar Corp assists Preformed Crown companies with:

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