21 CFR § 872.3661 - Optical Impression Systems for CAD/CAM.

---
identifier: "/us/cfr/t21/s872.3661"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 872.3661 - Optical Impression Systems for CAD/CAM."
title_number: 21
title_name: "Food and Drugs"
section_number: "872.3661"
section_name: "Optical Impression Systems for CAD/CAM."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "872"
part_name: "DENTAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 30097, Aug. 12, 1987, unless otherwise noted."
cfr_part: "872"
---


# 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 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).

[68 FR 19738, Apr. 22, 2003]