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U.S. FDA Medical Device Resin Applicator Requirements

FDA Medical Device Definition: A resin applicator is a brushlike device intended for use in spreading dental resin on a tooth during application of tooth shade material.

Registrar Corp assists Resin Applicator companies with:

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