21 CFR 872.1500
§ 872.1500 Gingival fluid measurer.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 872.1500, § 872.1500 Gingival fluid measurer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90043
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Full text
(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 of this chapter subject to the limitations in § 872.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.