§ 872.1500. Gingival fluid measurer.
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/us/cfr/t21/s§ 872.1500·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A gingival fluid measurer is a gauge device intended to measure the amount of fluid in the gingival sulcus (depression between the tooth and gums) to determine if there is a gingivitis 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. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38797, July 25, 2001]