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U.S. FDA Medical Device Prophylaxis Cup Requirements


FDA Medical Device Definition: A prophylaxis cup is a device made of rubber intended to be held by a dental handpiece and used to apply polishing agents during prophylaxis (cleaning). The dental handpiece spins the rubber cup holding the polishing agent and the user applies it to the teeth to remove debris.

Registrar Corp assists Prophylaxis Cup companies with:

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