510(k) K253009

DS Core Detect by Dentsply Sirona, Inc. — Product Code MYN

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

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