Title 21: Food and Drugs
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/ PART 872 - DENTAL DEVICES
/ Subpart G - Miscellaneous Devices / § 872.6510 Oral irrigation unit.
§ 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.