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U.S. FDA Medical Device Mechanical Denture Cleaner Requirements


FDA Medical Device Definition: A mechanical denture cleaner is a device, usually AC-powered, that consists of a container for mechanically agitating a denture cleansing solution. The device is intended to clean a denture by submersion in the agitating cleansing solution in the container.

Registrar Corp assists Mechanical Denture Cleaner companies with:

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