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U.S. FDA Medical Device Orthodontic Wire 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 Wire companies with:

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