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U.S. FDA Medical Device Manual Toothbrush Requirements

FDA Medical Device Definition: A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.

Registrar Corp assists Manual Toothbrush companies with:

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