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HomeMedical Devices510(k) Administrative ReviewMedical Device 510(k) Examples › U.S. FDA Denture Relining, Repairing, or Rebasing Resin Regulations

U.S. FDA Medical Device Denture Relining, Repairing, or Rebasing Resin Requirements: Denture Relining, Repairing, or Rebasing Resin

FDA Medical Device Definition: A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use

Registrar Corp assists Denture Relining, Repairing, or Rebasing Resin companies with:

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