Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3661](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3661) → NOF — System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

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

_Dental · 21 CFR 872.3661 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NOF

## Overview

- **Product Code:** NOF
- **Device Name:** System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- **Regulation:** [21 CFR 872.3661](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3661)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)

## Identification

An optical impression system for computer assisted design and manufacturing (CAD/CAM) 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-assisted 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.

## Classification Rationale

Class II (Special Controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of the chapter subject to the limitations in § 872.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA.” For the availability of this guidance document, see § 872.1(e).

## Special Controls

*Classification.* Class II (Special Controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of the chapter subject to the limitations in § 872.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA.” For the availability of this guidance document, see § 872.1(e).

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K141611](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NOF/K141611.md) | LYTHOS DIGITAL IMPRESSION SYSTEM | Ormco Corp. | Dec 5, 2014 | SESE |
| [K122065](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NOF/K122065.md) | DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE | Ormco Corp. | Feb 8, 2013 | SESE |
| [K122467](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NOF/K122467.md) | 3M TRUE DEFINITION SCANNER | 3M Company | Nov 20, 2012 | SESE |
| [K081961](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NOF/K081961.md) | 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER | Brontes Technologies | Sep 5, 2008 | SESE |
| [K073199](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NOF/K073199.md) | 3M ESPE LAVA CHAIRSIDE ORAL SCANNER | Brontes Technologies | Dec 21, 2007 | SESE |

## Top Applicants

- Brontes Technologies — 2 clearances
- Ormco Corp. — 2 clearances
- 3M Company — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NOF](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NOF)

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