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System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

FDA product code NOF · 4 cleared devices

Class 2 Dental
Regulation
21 CFR 872.3661
Review panel
DE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2007-12-21 – 2013-02-08

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.

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