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U.S. FDA Medical Device Disk Guard 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 Disk Guard companies with:

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