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U.S. FDA Medical Device Tube Impression & Matrix Requirements


FDA Medical Device Definition: An impression tube is a device consisting of a hollow copper tube intended to take an impression of a single tooth. The hollow tube is filled with impression material. One end of the tube is sealed with a softened material, such as wax, the remaining end is slipped over the tooth to make the impression.

Registrar Corp assists Tube Impression & Matrix companies with:

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