Overjet CBCT Assist

K251514

Overjet, Inc. · cleared 2025-12-05 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“Overjet CBCT Assist (OCBCTA) is a cloud-based software designed to assist dental professionals in the visualization and assessment of Cone Beam Computed Tomography (CBCT) images.”

Algorithmmachine learning-based segmentation algorithms

source quote (p.5)

“Overjet CBCT Assist uses machine learning-based segmentation algorithms to automatically identify and label anatomical and restorative structures, including permanent teeth, maxillofacial anatomy, and prior dental treatments such as implants, root canal therapy, crowns, and fillings.”

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)

Bench

sample size not stated

standards: IEC 62304:2006+A1:2015

Standalone

n=100 scans

endpoints: Instance-level sensitivity for dental anatomy, restorative structures, and maxillofacial anatomy; Instance-level specificity for restorative structures; Dice similarity coefficient for all segmented structures; Measurement accuracy (Mean Absolute Error (MAE) and Root Mean Square Error (RMSE)) for automated linear measurements displayed in MPR views; Tooth-level sensitivity and accuracy for tooth numbering

Reported performance (2 observations)

sensitivity93.9CI (91.7%, 95.9%)

source quote (p.11)

“the instance-level sensitivity for dental anatomy was 93.9% with 95% CI (91.7%, 95.9%)”

sensitivityas written: “Instance-level sensitivity for restorative structures”87CI (82.3%, 91.2%)

source quote (p.11)

“the observed instance-level sensitivity for restorative structures was 87.0% with 95% CI (82.3%, 91.2%)”

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).