Title 21: Food and Drugs
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/ PART 872 - DENTAL DEVICES
/ Subpart B - Diagnostic Devices / § 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.