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U.S. FDA Medical Device Impression Material Requirements: Impression Material

FDA Medical Device Definition: Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures

Registrar Corp assists Impression Material companies with:

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

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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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