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.”
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)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Standalone

n=100 scans

endpoints: panoramic curve proposal success rate (PCPSR)

Retrospective clinical

sample size not stated

endpoints: 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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K250755