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U.S. FDA Medical Device Shellac Base Plate Requirements

FDA Medical Device Definition: Base plant shellac is a device composed of shellac intended to rebuild the occlusal rim of full or partial dentures.

Registrar Corp assists Shellac Base Plate companies with:

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