System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
NOF · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.3661
Classification
FDA Product Code
NOF
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 872.3661
Review panel
DE
Medical specialty
Dental
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.