K250771 is an FDA 510(k) clearance for the Primescan 2. This device is classified as a Caries Detector, Laser Light, Transmission (Class II - Special Controls, product code NTK).
Submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on August 29, 2025, 169 days after receiving the submission on March 13, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.1745.
| 510(k) Number | K250771 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 2025 |
| Decision Date | August 29, 2025 |
| Days to Decision | 169 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 |