Oral irrigation unit.

21 C.F.R. § 872.6510
in effectEffective: 2024-07-01
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(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.

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