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

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