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

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