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U.S. FDA Medical Device Dental Handpiece and Accessories Requirements: Dental Handpiece and Accessories

FDA Medical Device Definition: A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth

Registrar Corp assists Dental Handpiece and Accessories companies with:

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