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U.S. FDA Medical Device Intraoral Dental Wax Requirements

FDA Medical Device Definition: Intraoral dental wax is a device made of wax intended to construct patterns from which custom made metal dental prostheses, such as crowns and bridges, are cast. In orthodontic dentistry, the device is intended to make a pattern of a patient's bite to make study models of the teeth.

Registrar Corp assists Intraoral Dental Wax companies with:

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