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U.S. FDA Medical Device Orthodontic Material 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 Material Band companies with:

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