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U.S. FDA Medical Device Articulators Requirements

FDA Medical Device Definition: An articulator is a mechanical device intended to simulate movements of a patient's upper and lower jaws. Plaster casts of the patient's teeth and gums are placed in the device to reproduce the occlusion (bite) and articulation of the patient's jaws. An articulator is intended to fit dentures or provide orthodontic treatment.

Registrar Corp assists Articulators companies with:

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