Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart G — Miscellaneous Devices](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices) → [21 CFR 872.6475](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6475) → EEG — Heat Source For Bleaching Teeth

# EEG · Heat Source For Bleaching Teeth

_Dental · 21 CFR 872.6475 · Class 1_

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

## Overview

- **Product Code:** EEG
- **Device Name:** Heat Source For Bleaching Teeth
- **Regulation:** [21 CFR 872.6475](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6475)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## 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.

## 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 (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K122725](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEG/K122725.md) | TANDA PEARL, ULTRAWYTE, PEARL | Syneron Beauty | Nov 27, 2012 | SESE |
| [K110888](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEG/K110888.md) | ABSOLUTE WHITE LIGHT | Dr. Fresh, Inc. | Jan 12, 2012 | SESE |
| [K063704](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEG/K063704.md) | BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 | Beks Incorporated | Feb 20, 2007 | SESE |
| [K052040](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEG/K052040.md) | QUICKSMILE | Cosmetic Dental Materials, Inc. | Oct 18, 2005 | SESE |
| [K042153](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEG/K042153.md) | SOUTH BEACH SMILE LIGHT WHITENING SYSTEM | Dentovations, Inc. | Nov 8, 2004 | SESE |
| [K041392](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEG/K041392.md) | SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US | CAO Group, Inc. | Nov 8, 2004 | SESE |
| [K895174](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEG/K895174.md) | UNION BROACH BLEACHING LIGHT | Union Broach, Div. Moyco Industries, Inc. | Apr 13, 1990 | SESE |
| [K884937](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEG/K884937.md) | BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING | Grass-Telefactor Product Group | Apr 14, 1989 | SESE |
| [K862385](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEG/K862385.md) | SCHEIN BLEACHING UNIT | Henry Schein, Inc. | Oct 30, 1986 | SESE |
| [K854692](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEG/K854692.md) | MONARCH II BLEACHING INSTRUMENT | Almore Intl., Inc. | May 12, 1986 | SESE |
| [K832179](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEG/K832179.md) | HOT PROBE MODEL 6001 | Analytic Technology | Oct 4, 1983 | SESE |
| [K790378](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEG/K790378.md) | REYNOLDS BLEACHING PROCESS | Reynolds Laboratories | Apr 10, 1979 | SESE |

## Top Applicants

- Almore Intl., Inc. — 1 clearance
- Analytic Technology — 1 clearance
- Beks Incorporated — 1 clearance
- CAO Group, Inc. — 1 clearance
- Cosmetic Dental Materials, Inc. — 1 clearance

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

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