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U.S. FDA Medical Device Dental Protector Requirements

FDA Medical Device Definition: A dental protector is a device intended to protect a patient's teeth during manipulative procedures within a patient's oral cavity.

Registrar Corp assists Dental Protector companies with:

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