Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart B — Diagnostic Devices](/submissions/DE/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 872.1730](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1730) → EAS — Gel, Electrode, For Pulp Tester

# EAS · Gel, Electrode, For Pulp Tester

_Dental · 21 CFR 872.1730 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAS

## Overview

- **Product Code:** EAS
- **Device Name:** Gel, Electrode, For Pulp Tester
- **Regulation:** [21 CFR 872.1730](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1730)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## 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._

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAS](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAS)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
