DS Core Detect
K253009Dentsply 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
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 scans
endpoints: Sensitivity; Specificity
Reader study (MRMC)
n=11 other
endpoints: AUC; Sensitivity; Specificity
Reported performance (10 observations)
sensitivity0.66CI [0.62; 0.70]
source quote (p.7)
“Standard sensitivity 0.66 [0.62; 0.70]”
specificity0.97CI [0.97; 0.98]
source quote (p.7)
“Standard sensitivity 0.97 [0.97; 0.98]”
sensitivityas written: “High sensitivity Standalone Sensitivity”0.78CI [0.74; 0.81]
source quote (p.7)
“High sensitivity 0.78 [0.74; 0.81]”
sensitivityas written: “High sensitivity Standalone Specificity”0.93CI [0.92; 0.94]
source quote (p.7)
“High sensitivity 0.93 [0.92; 0.94]”
aurocas written: “MRMC Aided AUC”0.639CI (0.529, 0.749)
source quote (p.7)
“0.639 (0.529, 0.749)”
aurocas written: “MRMC Unaided AUC”0.415CI (0.279, 0.550)
source quote (p.7)
“0.415 (0.279, 0.550)”
sensitivityas written: “MRMC Aided Sensitivity”0.649CI (0.535, 0.763)
source quote (p.7)
“0.649 (0.535, 0.763)”
sensitivityas written: “MRMC Unaided Sensitivity”0.421CI (0.281, 0.562)
source quote (p.7)
“0.421 (0.281, 0.562)”
specificityas written: “MRMC Aided Specificity”0.946CI (0.915, 0.976)
source quote (p.7)
“0.946 (0.915, 0.976)”
specificityas written: “MRMC Unaided Specificity”0.962CI (0.928, 0.995)
source quote (p.7)
“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). 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).