Overjet Dental Assist

K210187

Overjet, Inc. · cleared 2021-05-19 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
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.”
Algorithmsemi-automated image processing software device utilizes key points to measure interproximal bone levels
source quote (p.7)
“Overjet Dental Assist utilizes key points to measure interproximal bone levels.”
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

n=8,777 images

endpoints: precision; recall

standards: FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Retrospective clinical

n=63 patients

endpoints: sensitivity; specificity; mean absolute difference

Reported performance (12 observations)

sensitivity0.987
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.”
specificity0.9747
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.”
ppvas written: “Average Precision (Bitewing)”0.823
source quote (p.7)
“Average Precision 82.3%”
sensitivityas written: “Average Recall (Bitewing)”0.895
source quote (p.7)
“Average Recall 89.5%”
ppvas written: “Average Precision (Periapical)”0.83
source quote (p.7)
“Average Precision 83.0%”
sensitivityas written: “Average Recall (Periapical)”0.9
source quote (p.7)
“Average Recall 90.0%”
sensitivityas written: “Sensitivity (Bitewing)”0.987
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.”
specificityas written: “Specificity (Bitewing)”0.95
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.”
sensitivityas written: “Sensitivity (Periapical - interproximal bone levels)”0.8894
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.”
specificityas written: “Specificity (Periapical - interproximal bone levels)”0.9596
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.”
sensitivityas written: “Sensitivity (Periapical - Periapical Root Length)”0.909
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.”
specificityas written: “Specificity (Periapical - Periapical Root Length)”0.9747
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

48
recalls in product code, 24mo
295
MAUDE reports in code, 12mo
+683%
vs code's own 3-yr baseline
26
drift signals on this device
  • 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); 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 2026-07-08.

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).

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.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K210187