EEG
12 FDA 510(k) clearances · Product code
128 daysmedian time to decision
249 days90th percentile
12clearances measured
FDA profile
- Official device name
- Heat Source For Bleaching Teeth
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.6475
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2008: 3 · 2010: 3 · 2011: 7 · 2014: 7 · 2016: 8 · 2017: 10
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TANDA PEARL, ULTRAWYTE, PEARL (K122725) | Syneron Beauty | 2012-11-27 |
| ABSOLUTE WHITE LIGHT (K110888) | Dr. Fresh, Inc. | 2012-01-12 |
| BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 (K063704) | Beks Incorporated | 2007-02-20 |
| QUICKSMILE (K052040) | Cosmetic Dental Materials, Inc. | 2005-10-18 |
| SOUTH BEACH SMILE LIGHT WHITENING SYSTEM (K042153) | Dentovations, Inc. | 2004-11-08 |
| SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US (K041392) | CAO Group, Inc. | 2004-11-08 |
| UNION BROACH BLEACHING LIGHT (K895174) | Union Broach, Div. Moyco Industries, Inc. | 1990-04-13 |
| BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING (K884937) | Grass-Telefactor Product Group | 1989-04-14 |
| SCHEIN BLEACHING UNIT (K862385) | Henry Schein, Inc. | 1986-10-30 |
| MONARCH II BLEACHING INSTRUMENT (K854692) | Almore Intl., Inc. | 1986-05-12 |
| HOT PROBE MODEL 6001 (K832179) | Analytic Technology | 1983-10-04 |
| REYNOLDS BLEACHING PROCESS (K790378) | Reynolds Laboratories | 1979-04-10 |
Track EEG automatically
Every clearance here is in the API, with alerts when new ones post.