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.
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
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U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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