NOF

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

Product code

NOF

Device name

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

Device class

Class 2

21 CFR

21 CFR 872.3661

Medical specialty

Dental

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

5 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).