NOF

5 FDA 510(k) clearances · Product code

FDA profile

Official device name

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

Device class

Class II (moderate risk)

Regulation

21 CFR 872.3661

Medical specialty

Dental

FDA 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.

Adverse events (MAUDE)

2011: 5 · 2016: 10
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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