ABSOLUTE WHITE LIGHT
FDA 510(k) clearance K110888 · decided 2012-01-12
Clearance details
- K-number
- K110888
- Device name
- ABSOLUTE WHITE LIGHT
- Applicant
- Dr. Fresh, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-03-30
- Decision date
- 2012-01-12
- Days to decision
- 288 days
- Clearance type
- Traditional
- Product code
- EEG
- Device class
- 1
- Regulation number
- 872.6475
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TANDA PEARL, ULTRAWYTE, PEARL (K122725) | Syneron Beauty | 2012-11-27 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.