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U.S. FDA Medical Device Dental Amalgamator Requirements

FDA Medical Device Definition: A dental amalgamator is a device, usually AC-powered, intended to mix, by shaking, amalgam capsules containing mercury and dental alloy particles, such as silver, tin, zinc, and copper. The mixed dental amalgam material is intended for filling dental caries.

Registrar Corp assists Dental Amalgamator companies with:

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