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U.S. FDA Medical Device Lead-Lined Radiographic Cone Requirements


FDA Medical Device Definition: A lead-lined position indicator is a cone-shaped device lined with lead that is attached to a dental x-ray tube and intended to aid in positioning the tube, to prevent the misfocusing of the x-rays by absorbing divergent radiation, and to prevent leakage of radiation.

Registrar Corp assists Lead-Lined Radiographic Cone companies with:

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