21 CFR 872.6510
§ 872.6510 Oral irrigation unit.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 872.6510, § 872.6510 Oral irrigation unit, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90171
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Full text
(a) Identification. An oral irrigation unit is an AC-powered device intended to provide a pressurized stream of water to remove food particles from between the teeth and promote good periodontal (gum) 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.