The following data is part of a premarket notification filed by Air Techniques, Inc. with the FDA for Spectra Fluorescence Caries Detection Device.
| Device ID | K090169 |
| 510k Number | K090169 |
| Device Name: | SPECTRA FLUORESCENCE CARIES DETECTION DEVICE |
| Classification | Laser, Fluorescence Caries Detection |
| Applicant | AIR TECHNIQUES, INC. 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Contact | Natalya Valerio |
| Correspondent | Natalya Valerio AIR TECHNIQUES, INC. 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Product Code | NBL |
| CFR Regulation Number | 872.1745 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-23 |
| Decision Date | 2009-08-18 |
| Summary: | summary |