K090169 is an FDA 510(k) clearance for the SPECTRA FLUORESCENCE CARIES DETECTION DEVICE. This device is classified as a Laser, Fluorescence Caries Detection (Class II - Special Controls, product code NBL).
Submitted by Air Techniques, Inc. (Great Neck, US). The FDA issued a Cleared decision on August 18, 2009, 207 days after receiving the submission on January 23, 2009.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.1745.
| 510(k) Number | K090169 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2009 |
| Decision Date | August 18, 2009 |
| Days to Decision | 207 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NBL - Laser, Fluorescence Caries Detection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1745 |