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U.S. FDA Medical Device Extraoral Orthodontic Headgear Requirements: Extraoral Orthodontic Headgear

FDA Medical Device Definition: An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth from outside the mouth. The headgear has a strap intended to wrap around the patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth

Registrar Corp assists Extraoral Orthodontic Headgear companies with:

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




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U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


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