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U.S. FDA Medical Device Preformed Bar Requirements

FDA Medical Device Definition: A precision attachment or preformed bar is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended for use in prosthetic dentistry in conjunction with removable partial dentures. Various forms of the device are intended to connect a lower partial denture with another lower partial denture, to connect an upper partial denture with another upper partial denture, to connect either an upper or lower partial denture to a tooth or a crown, or to connect a fixed bridge to a partial denture.

Registrar Corp assists Preformed Bar companies with:

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