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

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