---
kind: "section"
citation: "21 C.F.R. § 872.3661"
title: "21"
number: "872.3661"
heading: "Optical Impression Systems for CAD/CAM."
url: "https://uscodex.org/cfr/21/872.3661"
---

# §872.3661. Optical Impression Systems for CAD/CAM.

- (a) **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.
- (b) **Classification.** Class II (Special Controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of the chapter subject to the limitations in [§ 872.9](/cfr/21/872.9.md). 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)](/cfr/21/872.1.md?p=e).

## Notes

### Amendments

[68 FR 19738, Apr. 22, 2003]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 30097, Aug. 12, 1987, unless otherwise noted.

### Amendments

[68 FR 19738, Apr. 22, 2003]