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U.S. FDA Medical Device Root Canal Post Requirements


FDA Medical Device Definition: A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.

Registrar Corp assists Root Canal Post companies with:

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