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U.S. Department of Health and Human Services

Product Classification
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Device system, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations
Regulation Description Optical Impression Systems for CAD/CAM.
Definition An optical impression system for cad/cam of dental restorations 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 aided 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.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeNOF
Submission Type 510(K) Exempt
Regulation Number 872.3661
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of Class II (special controls) devices subject to certain limitations, that are now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet a requirement of the Modernization Act.
Guidance Document
  • Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA
Third Party Review Not Third Party Eligible
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