DS Core Detect

K253009

Dentsply Sirona, Inc. · cleared 2026-01-07 · product code MYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“The DS Core Detect device is a cloud-based SaMD that is a Computer Aided Detection "CADe" Machine Learning "ML" enabled device for the aid in incidental detection of permanent teeth that may have periapical radiolucency "PARL" on a CBCT image.”
AlgorithmComputer Aided Detection (CADe) Machine Learning (ML) enabled device
source quote (p.5)
“The DS Core Detect device is a cloud-based SaMD that is a Computer Aided Detection "CADe" Machine Learning "ML" enabled device for the aid in incidental detection of permanent teeth that may have periapical radiolucency "PARL" on a CBCT image.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Standalone

n=306 cases

endpoints: sensitivity; specificity

Reader study (MRMC)

sample size not stated

endpoints: AUC; sensitivity; specificity

Reported performance (10 observations)

sensitivity0.78CI [0.74; 0.81]
source quote (p.7)
“1. Sensitivity: High sensitivity 0.78 [0.74; 0.81], Standard sensitivity 0.66 [0.62; 0.70]”
specificity0.93CI [0.92; 0.94]
source quote (p.7)
“2. Specificity: High sensitivity 0.93 [0.92; 0.94], Standard sensitivity 0.97 [0.97; 0.98]”
aurocas written: “auc”0.639CI (0.529, 0.749)
source quote (p.7)
“OR Model-Based AUC Estimates (95% Cls) Aided 0.639 (0.529, 0.749)”
sensitivityas written: “Standard sensitivity”0.66CI [0.62; 0.70]
source quote (p.7)
“1. Sensitivity: High sensitivity 0.78 [0.74; 0.81], Standard sensitivity 0.66 [0.62; 0.70]”
specificityas written: “Standard specificity”0.97CI [0.97; 0.98]
source quote (p.7)
“2. Specificity: High sensitivity 0.93 [0.92; 0.94], Standard sensitivity 0.97 [0.97; 0.98]”
aurocas written: “Unaided AUC”0.415CI (0.279, 0.550)
source quote (p.7)
“OR Model-Based AUC Estimates (95% Cls) Unaided 0.415 (0.279, 0.550)”
sensitivityas written: “Aided Tooth Level Sensitivity”0.649CI (0.535, 0.763)
source quote (p.7)
“Tooth Level Sensitivity (95% Cls) Aided 0.649 (0.535, 0.763)”
sensitivityas written: “Unaided Tooth Level Sensitivity”0.421CI (0.281, 0.562)
source quote (p.7)
“Tooth Level Sensitivity (95% Cls) Unaided 0.421 (0.281, 0.562)”
specificityas written: “Aided Tooth Level Specificity”0.946CI (0.915, 0.976)
source quote (p.7)
“Tooth Level Specificity (95% CIs) Aided 0.946 (0.915, 0.976)”
specificityas written: “Unaided Tooth Level Specificity”0.962CI (0.928, 0.995)
source quote (p.7)
“Tooth Level Specificity (95% CIs) Unaided 0.962 (0.928, 0.995)”

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
0
MAUDE reports in code, 12mo
-100%
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/K253009