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

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