§ 868.5820. Dental protector.
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/us/cfr/t21/s§ 868.5820·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]