DS Core Diagnosis

K250755

Dentsply Sirona Inc. · cleared 2025-08-12 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“DS Core Diagnosis is a cloud-based dental imaging software that provides access to dental media and images via an active internet connection. It is a medical device that can only be used in combination with the DS Core Platform. Classified as a Class II dental imaging software, DS Core Diagnosis allows users to view a variety of media types, including 2D and 3D images (e.g., bitewings, periapicals, panoramic, CBCT, etc.), as well as photos and documentation.”

AlgorithmMachine Learning enabled panoramic curve proposal algorithm, Convolutional Neural Network (CNN) model

source quote (p.5)

“DS Core Diagnosis also features a Machine Learning enabled panoramic curve proposal algorithm for a proposed panoramic curve of a CBCT scan along the dental arch, which can be adjusted and reviewed by the user. The architecture is a Convolutional Neural Network (CNN) model.”

Adaptive (vs locked)No

source quote (p.7)

“Regardless of this strong performance, the users of the device retain full autonomy and can adjust and review the proposed panoramic curve.”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

n=100 scans

endpoints: panoramic curve proposal success rate (PCPSR)

Reader study (MRMC)

sample size not stated

endpoints: determine the clinical acceptability (pass/fail) of the CBCT reconstructed panoramic images based on the panoramic curve proposal (without user modification) to begin working per the standard of care.

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).