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U.S. FDA Medical Device Dental Bur Requirements

FDA Medical Device Definition: A dental bur is a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone. It is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices.

Registrar Corp assists Dental Bur companies with:

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