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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodeNOF
Regulation Number 872.3661
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ORMCO CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Electrical power problem 4
Environmental control or utility issue 4
Flammable 1
Total Device Problems 9

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