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

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