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U.S. FDA Medical Device Amalgam Dental Capsule Requirements


FDA Medical Device Definition: A dental amalgam capsule is a container device in which silver alloy is intended to be mixed with mercury to form dental amalgam.

Registrar Corp assists Amalgam Dental Capsule companies with:

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