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U.S. FDA Medical Device Color Scanner Requirements

FDA Medical Device Definition: An optical impression system for computer assisted design and manufacturing (CAD/CAM) is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer-assisted design and manufacturing of dental restorative prosthetic devices. Such systems may consist of a camera, scanner, or equivalent type of sensor and a computer with software.

Registrar Corp assists Color Scanner companies with:

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