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Title 21 → Chapter I → Subchapter H → Part 872 → Subpart B → §872.1500 |
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart B—Diagnostic Devices
§872.1500 Gingival fluid measurer.
(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]