Dental protector.

21 C.F.R. § 868.5820
in effectEffective: 2024-07-01
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(a) Identification. A dental protector is a device intended to protect a patient's teeth during manipulative procedures within a patient's oral cavity. (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 § 868.9.

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