← Product Code [EAT](/productcode/EAT) · K790799

# PULPTESTER MODEL 2001 (K790799)

_Analytic Technology · EAT · May 31, 1979 · Dental · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K790799

## Device Facts

- **Applicant:** Analytic Technology
- **Product Code:** [EAT](/productcode/EAT.md)
- **Decision Date:** May 31, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.1720
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

A pulp tester is an AC or battery powered device intended to evaluate the pulpal vitality of teeth by employing high frequency current transmitted by an electrode to stimulate the nerve tissue in the dental pulp.

## Special Controls

*Classification.* Class II (special 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.

---

**Source:** [https://fda-staging.innolitics.com/device/K790799](https://fda-staging.innolitics.com/device/K790799)

**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
