---
kind: "section"
citation: "21 C.F.R. § 872.6640"
title: "21"
number: "872.6640"
heading: "Dental operative unit and accessories."
url: "https://uscodex.org/cfr/21/872.6640"
---

# §872.6640. Dental operative unit and accessories.

- (a) **Identification.** A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.
- (b) **Classification.** Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 872.9](/cfr/21/872.9.md).

## Notes

### Amendments

[55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 65 FR 2315, Jan. 14, 2000]

### 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

[55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 65 FR 2315, Jan. 14, 2000]