K121685 is an FDA 510(k) clearance for the SOPROCARE. This device is classified as a Laser, Fluorescence Caries Detection (Class II - Special Controls, product code NBL).
Submitted by Sopro (Mt. Laurel, US). The FDA issued a Cleared decision on March 12, 2013, 278 days after receiving the submission on June 7, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.1745.
| 510(k) Number | K121685 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2012 |
| Decision Date | March 12, 2013 |
| Days to Decision | 278 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 |