21 CFR § 872.6510 - Oral irrigation unit.

---
identifier: "/us/cfr/t21/s872.6510"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 872.6510 - Oral irrigation unit."
title_number: 21
title_name: "Food and Drugs"
section_number: "872.6510"
section_name: "Oral irrigation unit."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "872"
part_name: "DENTAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 30097, Aug. 12, 1987, unless otherwise noted."
cfr_part: "872"
---


# 872.6510 Oral irrigation unit.

(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.

[55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38800, July 25, 2001]