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U.S. FDA Medical Device X-Ray Collimator Requirements

FDA Medical Device Definition: A dental x-ray position indicating device is a device, such as a collimator, cone, or aperture, that is used in dental radiographic examination. The device is intended to align the examination site with the x-ray beam and to restrict the dimensions of the dental x-ray field by limiting the size of the primary x-ray beam.

Registrar Corp assists X-Ray Collimator companies with:

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