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U.S. FDA Medical Device Facebow Requirements

FDA Medical Device Definition: A facebow is a device intended for use in denture fabrication to determine the spatial relationship between the upper and lower jaws. This determination is intended for use in placing denture casts accurately into an articulator (872.3150) and thereby aiding correct placement of artificial teeth into a denture base.

Registrar Corp assists Facebow companies with:

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