Cleared Traditional

K253009 - DS Core Detect (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K253009 is an FDA 510(k) clearance for the DS Core Detect. Classified as Analyzer, Medical Image (product code MYN), Class II - Special Controls.

Submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on January 7, 2026 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2070 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentsply Sirona, Inc. devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 107d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MYN Analyzer, Medical Image
Device Class Class 2 - 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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MYN Analyzer, Medical Image

All 35
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