FDA product code EEG: Heat Source For Bleaching Teeth
EEG is the FDA product code for heat source for bleaching teeth. It is a Class I device, regulated under 21 CFR 872.6475 and reviewed by the Dental panel. FDA has cleared 12 510(k) submissions under EEG, from 12 different applicants. The average 510(k) review took 134 days (median 110).
Classification
| Field | Value |
|---|---|
| Device name | Heat Source For Bleaching Teeth |
| Device class | Class I |
| Regulation | 21 CFR 872.6475 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EEG clearance
Top EEG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syneron Beauty | 1 | 2012-11-27 |
| Dr. Fresh, Inc. | 1 | 2012-01-12 |
| Beks Incorporated | 1 | 2007-02-20 |
| Cosmetic Dental Materials, Inc. | 1 | 2005-10-18 |
| CAO Group, Inc. | 1 | 2004-11-08 |
7 more applicants have EEG clearances. See the full list in Caduvo.
Most recent EEG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K122725 | Syneron Beauty | TANDA PEARL, ULTRAWYTE, PEARL | 2012-11-27 | 83 |
| K110888 | Dr. Fresh, Inc. | ABSOLUTE WHITE LIGHT | 2012-01-12 | 288 |
| K063704 | Beks Incorporated | BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 | 2007-02-20 | 69 |
| K052040 | Cosmetic Dental Materials, Inc. | QUICKSMILE | 2005-10-18 | 82 |
| K041392 | CAO Group, Inc. | SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US | 2004-11-08 | 167 |
Recalls for EEG devices
openFDA lists no recalls for product code EEG.
Frequently asked questions
What is FDA product code EEG?
EEG is the FDA product code for heat source for bleaching teeth. It is a Class I device, regulated under 21 CFR 872.6475 and reviewed by the Dental panel.
What device class is EEG?
Class I, regulation 21 CFR 872.6475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EEG?
Across 12 cleared submissions the average was 134 days from receipt to decision (median 110).
Which companies have the most EEG clearances?
Syneron Beauty (1); Dr. Fresh, Inc. (1); Beks Incorporated (1); Cosmetic Dental Materials, Inc. (1); CAO Group, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EEG
- Run a recall and safety report across every EEG manufacturer
- Watch product code EEG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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