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U.S. FDA Medical Device Orthodontic Metal Bracket 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 Metal Bracket companies with:

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