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U.S. FDA Medical Device Orthodontic Preformed Band Requirements


FDA Medical Device Definition: An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.

Registrar Corp assists Orthodontic Preformed Band companies with:

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