EEG · Heat Source For Bleaching Teeth
Dental · 21 CFR 872.6475 · Class 1
Overview
| Product Code | EEG |
|---|---|
| Device Name | Heat Source For Bleaching Teeth |
| Regulation | 21 CFR 872.6475 |
| Device Class | Class 1 |
| Review Panel | Dental |
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 | TANDA PEARL, ULTRAWYTE, PEARL | Syneron Beauty | Nov 27, 2012 | SESE |
| K110888 | ABSOLUTE WHITE LIGHT | Dr. Fresh, Inc. | Jan 12, 2012 | SESE |
| K063704 | BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 | Beks Incorporated | Feb 20, 2007 | SESE |
| K052040 | QUICKSMILE | Cosmetic Dental Materials, Inc. | Oct 18, 2005 | SESE |
| K042153 | SOUTH BEACH SMILE LIGHT WHITENING SYSTEM | Dentovations, Inc. | Nov 8, 2004 | SESE |
| K041392 | SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US | CAO Group, Inc. | Nov 8, 2004 | SESE |
| K895174 | UNION BROACH BLEACHING LIGHT | Union Broach, Div. Moyco Industries, Inc. | Apr 13, 1990 | SESE |
| K884937 | BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING | Grass-Telefactor Product Group | Apr 14, 1989 | SESE |
| K862385 | SCHEIN BLEACHING UNIT | Henry Schein, Inc. | Oct 30, 1986 | SESE |
| K854692 | MONARCH II BLEACHING INSTRUMENT | Almore Intl., Inc. | May 12, 1986 | SESE |
| K832179 | HOT PROBE MODEL 6001 | Analytic Technology | Oct 4, 1983 | SESE |
| K790378 | REYNOLDS BLEACHING PROCESS | Reynolds Laboratories | Apr 10, 1979 | SESE |
Top Applicants
- Union Broach, Div. Moyco Industries, Inc. — 1 clearance
- Syneron Beauty — 1 clearance
- Reynolds Laboratories — 1 clearance
- Henry Schein, Inc. — 1 clearance
- Grass-Telefactor Product Group — 1 clearance
