K111423 is an FDA 510(k) clearance for the CS 1600 INTRAORAL CAMERA. This device is classified as a Laser, Fluorescence Caries Detection (Class II - Special Controls, product code NBL).
Submitted by Carestream Health, Inc. (Atlanta, US). The FDA issued a Cleared decision on March 2, 2012, 284 days after receiving the submission on May 23, 2011.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.1745.
| 510(k) Number | K111423 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2011 |
| Decision Date | March 02, 2012 |
| Days to Decision | 284 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 |