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

FDA Medical Device Definition: A dental operative unit 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 companies with:

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