CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 872—DENTAL DEVICES > SUBPART B—Diagnostic Devices (§872.1500 to §872.2060) > 872.1730—Electrode gel for pulp testers.

872.1730—Electrode gel for pulp testers.

(a) Identification. An electrode gel for pulp testers is a device intended to be applied to the surface of a tooth before use of a pulp tester to aid conduction of electrical current.
(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.

Code of Federal Regulations

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, 2001]