Overjet Charting Assist
K233590Overjet, Inc · cleared 2024-02-23 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“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.”
source quote (p.5)
“Both devices utilize AI based image analysis.”
Validation studies (1)
Retrospective clinical
n=634 images · 44 site(s)
endpoints: tooth level sensitivity of past restorative treatment; dental tooth anatomy; tooth level sensitivity (overall classification accuracy) of tooth numbering
Reported performance (9 observations)
source quote (p.7)
“Tooth level standalone sensitivity for past restorative structures was 88.3% with 95% CI's of (86.6%, 90.1%).”
source quote (p.7)
“Tooth Level standalone sensitivity for dental tooth anatomy (enamel/pulp) was 95.9% with 95% CI's of (95.1%, 96.5%).”
source quote (p.7)
“Tooth Level standalone sensitivity (Overall Classification Accuracy) for dental tooth numbering was 98.8% with 95% CI's of (98.4%, 99.1%).”
source quote (p.7)
“Dice for Dental Tooth Anatomy resulted in a Mean Std. Dev. 0.836 (0.098) with 95% CI's (0.832, 0.842).”
source quote (p.7)
“Dice for Past Restorative Structures resulted in a Mean Std. Dev. 0.918 (0.078) with 95% CI's (0.914, 0.923).”
source quote (p.7)
“PPV for dental tooth anatomy at the tooth level was 0.967 with 95% CI's of (0.960, 0.973)”
source quote (p.7)
“NPV for dental tooth anatomy at the tooth level was 0.710 with 95% CI's of (0.672, 0.745)”
source quote (p.7)
“PPV for past restorative structures at the tooth level was 0.958 with 95% CI's of (0.948, 0.967)”
source quote (p.7)
“NPV for past restorative structures at the tooth level was 0.945 with 95% CI's of (0.935, 0.954)”
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K241684 (decision 2024-08-27) from Overjet, Inc for a matching device line ("Overjet Charting Assist") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K241684
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).