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U.S. FDA Medical Device Denture Pad or Cushion Requirements


FDA Medical Device Definition: An OTC denture cushion or pad is a prefabricated or noncustom made disposable device that is intended to improve the fit of a loose or uncomfortable denture, and may be available for purchase over-the-counter.

Registrar Corp assists Denture Pad or Cushion companies with:

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