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U.S. FDA Medical Device Cavity Varnish Requirements: Cavity Varnish

FDA Medical Device Definition: Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue

Registrar Corp assists Cavity Varnish companies with:

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