DS Core Detect

K253009

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

FDA 510(k) summary for DS Core Detect (K253009)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
2
Cited predicates
1
Performance observations
10
Product code
MYN
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

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 2026-09-02.

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.

Related FDA clearances

More AI/ML devices under product code MYN

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

qXR-Detect

K251934

Qure.Ai Technologies

cleared 2026-01-16

Diagnocat

K252934

DGNCT, LLC

cleared 2026-01-15

DTX Studio Assist

K252086

Nobel Biocare C/O Medicim NV

cleared 2025-11-17

Second Opinion® Panoramic

K250525

Pearl, Inc.

cleared 2025-11-14

SugarBug (1.x)

K250264

Bench7, Inc.

cleared 2025-11-07

Videa Dental AI

K251002

VideaHealth Inc.

cleared 2025-09-19

VELMENI for DENTISTS (V4D)

K250753

Velmeni Inc.

cleared 2025-09-02

Second Opinion® CS

K243234

Pearl Inc.

cleared 2025-06-12

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K253009