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U.S. FDA Medical Device Preformed Impression Tray Requirements


FDA Medical Device Definition: A preformed impression tray is a metal or plastic device intended to hold impression material, such as alginate, to make an impression of a patient's teeth or alveolar process (bony tooth sockets) to reproduce the structure of a patient's teeth and gums.

Registrar Corp assists Preformed Impression Tray companies with:

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