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U.S. FDA Medical Device Dental Cement Requirements: Dental Cement

FDA Medical Device Definition: Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp

Registrar Corp assists Dental Cement companies with:

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