EAS · Gel, Electrode, For Pulp Tester
Dental · 21 CFR 872.1730 · Class 1
Overview
| Product Code | EAS |
|---|---|
| Device Name | Gel, Electrode, For Pulp Tester |
| Regulation | 21 CFR 872.1730 |
| Device Class | Class 1 |
| Review Panel | Dental |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
