← Product Code [EEG](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEG) · K862385

# SCHEIN BLEACHING UNIT (K862385)

_Henry Schein, Inc. · EEG · Oct 30, 1986 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEG/K862385

## Device Facts

- **Applicant:** Henry Schein, Inc.
- **Product Code:** [EEG](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEG.md)
- **Decision Date:** Oct 30, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.6475
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

A heat source for bleaching teeth is an AC-powered device that consists of a light or an electric heater intended to apply heat to a tooth after it is treated with a bleaching agent.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEG/K862385](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEG/K862385)

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