Cleared Traditional

DS Core Detect

K253009 · Dentsply Sirona, Inc. · Radiology
Jan 2026
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K253009 is an FDA 510(k) clearance for the DS Core Detect, 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 review panel. Regulated under 21 CFR 892.2070.

Submission Details

510(k) Number K253009 FDA.gov
FDA Decision Cleared 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

Device Classification

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