---
kind: "section"
citation: "21 C.F.R. § 872.1500"
title: "21"
number: "872.1500"
heading: "Gingival fluid measurer."
url: "https://uscodex.org/cfr/21/872.1500"
---

# §872.1500. Gingival fluid measurer.

- (a) **Identification.** A gingival fluid measurer is a gauge device intended to measure the amount of fluid in the gingival sulcus (depression between the tooth and gums) to determine if there is a gingivitis condition.
- (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 the limitations in [§ 872.9](/cfr/21/872.9.md).

## Notes

### Amendments

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38797, July 25, 2001]

### 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

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38797, July 25, 2001]