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U.S. FDA Medical Device Airbrush Requirements: Airbrush

FDA Medical Device Definition: An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper

Registrar Corp assists Airbrush companies with:

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

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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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