Overjet Dental Assist
K210187Overjet, Inc. · cleared 2021-05-19 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“Overjet Dental Assist is a cloud native Software as a Medical Device that allows users to automate the measurement of interproximal bone levels for bitewing and periapical radiographs, review associated radiographs, view annotations, modify annotations.”
source quote (p.4)
“Overjet Dental Assist developed by Overjet Inc, is a radiological semi automated image processing software device intended to aid dental professionals in the measurements of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs.”
Validation studies (2)
Bench
n=8,777 images
endpoints: precision; recall
Retrospective clinical
n=63 patients
endpoints: sensitivity; specificity; mean absolute difference; interproximal bone levels; Periapical Root Length
Reported performance (10 observations)
source quote (p.8)
“The Overjet Dental Assist software demonstrated a modeled 98.7% sensitivity value and 95.0% specificity value, and a mean absolute difference from the ground truth of 0.307mm for measurement of interproximal bone levels in bitewing radiographs.”
source quote (p.8)
“The Overjet Dental Assist software demonstrated a modeled 98.7% sensitivity value and 95.0% specificity value, and a mean absolute difference from the ground truth of 0.307mm for measurement of interproximal bone levels in bitewing radiographs.”
source quote (p.7)
“Average Precision 82.3%”
source quote (p.7)
“Average Recall 89.5%”
source quote (p.7)
“Average Precision 83.0%”
source quote (p.7)
“Average Recall 90.0%”
source quote (p.8)
“In interproximal bone levels in periapical radiographs, Overjet Dental Assist scored 88.94% sensitivity, 95.96% specificity, and 0.353mm mean absolute difference.”
source quote (p.8)
“In interproximal bone levels in periapical radiographs, Overjet Dental Assist scored 88.94% sensitivity, 95.96% specificity, and 0.353mm mean absolute difference.”
source quote (p.8)
“Performance of measurement of Periapical Root Length was measured at 90.9% sensitivity, 97.47% specificity, and 0.567mm mean absolute difference.”
source quote (p.8)
“Performance of measurement of Periapical Root Length was measured at 90.9% sensitivity, 97.47% specificity, and 0.567mm mean absolute difference.”
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
- adverse_event_inflection
MAUDE adverse-event reports for product code LLZ: 295 in the 12 months ending 2026-06, vs a 37.7/12mo average over the prior 3 windows (+683%). Code-level count — reports are not attributed to this specific device.
first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=LLZ
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems SCS, initiated 2026-05-08): "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:99042
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2026-03-05): "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98520
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems, LLC, initiated 2026-01-30): "There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98428
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (Focalyx Technologies, LLC., initiated 2025-12-23): "Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, wh" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98137
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (DICOM Grid, Inc., initiated 2025-11-18): "Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97993
- …and 20 more.
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).