21 CFR 872.1730 — Gel, Electrode, For Pulp Tester
Dental (DE) · Subpart B—Diagnostic Devices · § 872.1730
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EAS | Gel, Electrode, For Pulp Tester | 1 | 0 |
