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e-CFR data is current as of February 23, 2021 |
Title 21 → Chapter I → Subchapter H → Part 872 → Subpart B → §872.1720 |
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart B—Diagnostic Devices
§872.1720 Pulp tester.
(a) Identification. A pulp tester is an AC or battery powered device intended to evaluate the pulpal vitality of teeth by employing high frequency current transmitted by an electrode to stimulate the nerve tissue in the dental pulp.
(b) Classification. Class II (special 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 84 FR 71812, Dec. 30, 2019]