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U.S. FDA Medical Device Polishing Agent Wheel 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 Polishing Agent Wheel companies with:

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