K253009 is an FDA 510(k) clearance for the DS Core Detect. This device is classified as a Analyzer, Medical Image (Class II - Special Controls, product code MYN).
Submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on January 7, 2026, 110 days after receiving the submission on September 19, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2070. For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers.
| 510(k) Number | K253009 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2025 |
| Decision Date | January 07, 2026 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MYN — Analyzer, Medical Image |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2070 |
| Definition | For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers |