Overjet Charting Assist
K241684Overjet, Inc · cleared 2024-08-27 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.5)
“Overjet Charting Assist is a Medical Image Management and Processing System (MIMPS) device aimed to assist dental professionals in detecting dental structures and producing dental charting data based on interpretation of 2D dental radiographs.”
AlgorithmML model
source quote (p.7)
“Specifically, improvements resulting from re-training the ML model with new data.”
Adaptive (vs locked)No
source quote (p.7)
“The PCCP does not include any provisions for implementation of adaptive algorithms that will continuously learn in the field. In accordance with the PCCP, all algorithm modifications will be trained, tuned, and locked prior to release of the software to the field.”
PCCPYes
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP), “Predetermined Change Control Plan ‘PCCP' for Overjet Charting Assist,” Revision V1.”
Cybersecurity addressedFDA source did not state this
Validation studies (1)
Standalone
sample size not stated
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). 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).