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U.S. FDA Medical Device Disposable Fluoride Tray Requirements


FDA Medical Device Definition: An abrasive device and accessories is a device constructed of various abrasives, such as diamond chips, that are glued to shellac-based paper. The device is intended to remove excessive restorative materials, such as gold, and to smooth rough surfaces from oral restorations, such as crowns. The device is attached to a shank that is held by a handpiece. The device includes the abrasive disk, guard for an abrasive disk, abrasive point, polishing agent strip, and polishing wheel.

Registrar Corp assists Disposable Fluoride Tray companies with:

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