K123402 is an FDA 510(k) clearance for the DIAGNOCAM. This device is classified as a Caries Detector, Laser Light, Transmission (Class II - Special Controls, product code NTK).
Submitted by Kaltenbach & Voigt GmbH (Biberach / Riss, DE). The FDA issued a Cleared decision on September 24, 2013, 323 days after receiving the submission on November 5, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.1745.
| 510(k) Number | K123402 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2012 |
| Decision Date | September 24, 2013 |
| Days to Decision | 323 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NTK - Caries Detector, Laser Light, Transmission |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1745 |