← Product Code [EAT](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAT) · K950237

# DIGITEST (K950237)

_Parkell, Inc. · EAT · Jun 9, 1995 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAT/K950237

## Device Facts

- **Applicant:** Parkell, Inc.
- **Product Code:** [EAT](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAT.md)
- **Decision Date:** Jun 9, 1995
- **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.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAT/K950237](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAT/K950237)

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