# System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 5
- **Registered establishments:** 145
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NOF)
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