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U.S. FDA Medical Device Dental Floss Requirements

FDA Medical Device Definition: Dental floss is a string-like device made of cotton or other fibers intended to remove plaque and food particles from between the teeth to reduce tooth decay. The fibers of the device may be coated with wax for easier use.

Registrar Corp assists Dental Floss companies with:

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