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U.S. FDA Medical Device Zinc Oxide Eugenol Requirements

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 Zinc Oxide Eugenol companies with:

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