§ 872.6510. Oral irrigation unit.
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/us/cfr/t21/s§ 872.6510·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]