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U.S. FDA Medical Device Denture Cleanser Requirements

FDA Medical Device Definition: An OTC denture cleanser is a device that consists of material in the form of a powder, tablet, or paste that is intended to remove debris from removable prosthetic dental appliances, such as bridges or dentures. The dental appliance is removed from the patient's mouth when the appliance is cleaned.

Registrar Corp assists Denture Cleanser companies with:

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