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U.S. FDA Medical Device Preformed Tooth Positioner Requirements


FDA Medical Device Definition: A preformed tooth positioner is a plastic device that is an impression of a perfected bite intended to prevent a patient's teeth from shifting position or to move teeth to a final position after orthodontic appliances (braces) have been removed. The patient bites down on the device for several hours a day to force the teeth into a final position or to maintain the teeth in their corrected position.

Registrar Corp assists Preformed Tooth Positioner companies with:

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