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U.S. FDA Medical Device Pantograph Requirements

FDA Medical Device Definition: A pantograph is a device intended to be attached to a patient's head to duplicate lower jaw movements to aid in construction of restorative and prosthetic dental devices. A marking pen is attached to the lower jaw component of the device and, as the patient's mouth opens, the pen records on graph paper the angle between the upper and the lower jaw.

Registrar Corp assists Pantograph companies with:

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