21 C.F.R. § 872.6510

Current through November 30, 2024
Section 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 .

21 C.F.R. §872.6510

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