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U.S. FDA Medical Device Dental Operative Unit and Accessories Requirements: Dental Operative Unit and Accessories

FDA Medical Device Definition: A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair

Registrar Corp assists Dental Operative Unit and Accessories companies with:

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