---
kind: "section"
citation: "21 C.F.R. § 872.6300"
title: "21"
number: "872.6300"
heading: "Rubber dam and accessories."
url: "https://uscodex.org/cfr/21/872.6300"
---

# §872.6300. Rubber dam and accessories.

- (a) **Identification.** A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in [§ 884.5300](/cfr/21/884.5300.md) of this chapter.
- (b) **Classification.** Class I (general controls). The device is exempt from the 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). If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in [part 820](/cfr/21/part820.md) of this chapter, except for requirements concerning records and complaint files under [§ 820.35](/cfr/21/820.35.md) of this chapter.

## Notes

### Amendments

[65 FR 2315, Jan. 14, 2000, as amended at 90 FR 55984, Dec. 4, 2025]

### 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

[65 FR 2315, Jan. 14, 2000, as amended at 90 FR 55984, Dec. 4, 2025]