510(k) K253009
K253009 is an FDA 510(k) premarket notification submitted by Dentsply Sirona, Inc. for the device "DS Core Detect". The FDA issued a decision of Substantially Equivalent on January 7, 2026. The device falls under product code MYN (Analyzer, Medical Image), a Class II device regulated under 21 CFR 892.2070. Dentsply Sirona, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 2026
- Date Received
- September 19, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Medical Image
- Device Class
- Class II
- Regulation Number
- 892.2070
- Review Panel
- RA
- Submission Type
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