← Product Code [KZN](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KZN) · K770667

# CHROMASCAN TM (K770667)

_Sterndent Corp. · KZN · Apr 20, 1977 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KZN/K770667

## Device Facts

- **Applicant:** Sterndent Corp.
- **Product Code:** [KZN](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KZN.md)
- **Decision Date:** Apr 20, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3661
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory 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.

## 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).

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KZN/K770667](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KZN/K770667)

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