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

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