K252086 is an FDA 510(k) clearance for the DTX Studio Assist. This device is classified as a Analyzer, Medical Image (Class II - Special Controls, product code MYN).
Submitted by Nobel Biocare C/O Medicim NV (Mechelen, BE). The FDA issued a Cleared decision on November 17, 2025, 138 days after receiving the submission on July 2, 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 | K252086 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2025 |
| Decision Date | November 17, 2025 |
| Days to Decision | 138 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 |