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U.S. FDA Medical Device Dental Sonography Requirements

FDA Medical Device Definition: A dental sonography device for monitoring is an electrically powered device, intended to be used to monitor temporomandibular joint sounds. The device detects and records sounds made by the temporomandibular joint.

Registrar Corp assists Dental Sonography companies with:

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