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U.S. FDA Medical Device Gutta-Percha Requirements

FDA Medical Device Definition: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools.

Registrar Corp assists Gutta-Percha companies with:

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