21 CFR 872.5580
§ 872.5580 Oral rinse to reduce the adhesion of dental plaque.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 872.5580, § 872.5580 Oral rinse to reduce the adhesion of dental plaque, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90154
- Permanent ID
ys:prov:90154@1- SHA-256
80ed9e03c17fc8bc908fd2c1ca419e428c730e04d6f20bb91813dbeab8b38f5c
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Full text
(a) Identification. The device is assigned the generic name oral rinse to reduce the adhesion of dental plaque and is identified as a device intended to reduce the presence of bacterial plaque on teeth and oral mucosal surfaces by physical means. The device type includes those devices that act by reducing the attachment and inhibiting the growth of bacterial plaque.
(b) Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque.” See § 872.1(e) for the availability of this guidance document.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.