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U.S. FDA Medical Device Oral Cavity Evacuator Requirements

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 Oral Cavity Evacuator companies with:

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