Radiology AI Directory

FDA-cleared profile

Overjet CBCT Assist

Overjet, Inc.

Dental and craniomaxillofacial CBCT segmentation, measurement and visualization support

Quantification and segmentation
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
Dental and craniomaxillofacial CBCT segmentation, measurement and visualization support
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Intended users
Dental professionals
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Care setting and population
Adult
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.

Workflow role
Segmentation, measurement and visualization support
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Required input
Standard CBCT, enhanced CBCT and craniofacial 3D DICOM volumes
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Output and human action
Segmentations/labels for teeth, maxillofacial anatomy and restorations; manual/automated distance, area, angle and signal-intensity measures; MPR, 3D volume-rendering and PDF report.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Limitations
Diagnostic-support tool only; it does not replace complete clinician review or clinical judgment. It is limited to 3D CBCT and PDF output, not treatment-design export.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K251514
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CBCT
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Anatomy
Dental/Maxillofacial
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-12-05
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Web application using CBCT DICOM input and PDF report output
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Deployment and data flow
Hybrid
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Preserved prior baseline category. FDA summary calls the subject a web application; exact purchased hosting/data-flow configuration needs confirmation.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

No scoped dated security attestation reviewed.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Dental CBCT onboarding and local acceptance/training requirements require confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Post-deployment segmentation-error monitoring and update controls require confirmation.

Current CBCT Assist visualization

Vendor describes labeled teeth, restorations, sinuses and nerve canals with access from any computer.

product family ยท checked 2026-09-05

Practice outcome and ROI marketing claims were excluded; exact purchased configuration must be confirmed.

Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
Pivotal retrospective study used 100 CBCT scans independently annotated by three US-licensed oral and maxillofacial radiologists/dentists across multiple scanner manufacturers. FDA reports pre-specified goals met; it does not establish patient outcomes.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Reported sensitivity
93.9% (95% CI 91.7%-95.9%) for instance-level dental anatomy segmentation
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

100-scan retrospective segmentation endpoint, not diagnostic disease sensitivity.

Reported specificity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-05

Summary evaluates instance-level specificity for restorative structures but does not provide a usable single numeric estimate.

Instance-level dental anatomy sensitivity

93.9 %

  • EndpointAutomated dental-anatomy segmentation
  • PopulationRetrospective CBCT scans with expert annotations
  • Tested versionOverjet CBCT Assist v1 in K251514
Source

Instance-level restorative-structure sensitivity

87 %

  • EndpointAutomated restorative-structure segmentation
  • PopulationRetrospective CBCT scans with expert annotations
  • Tested versionOverjet CBCT Assist v1 in K251514
Source

K251514 CBCT Assist pivotal retrospective performance study

  • DesignRetrospective standalone segmentation and measurement accuracy study
  • PopulationDiverse CBCT scans from multiple manufacturers with three US-licensed oral/maxillofacial radiologist/dentist annotations
  • Scopeexact submission
  • Tested versionOverjet CBCT Assist v1
  • Samplen=100
  • IndependenceIndependence not established

K251514

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-06

Official demo pages do not publish a CBCT Assist rate or procurement quote.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-06

No applicable payer policy reviewed; vendor marketing statements about practice outcomes do not establish coverage.

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-06Last searched
22Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

Stored PubMed and clinical-trial arrays are empty and were screened. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, acr ai central product, vendor product page, literature index, trial registry, recall database, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. Overjet CBCT Assist: K251514 decision and 510(k) summary

    U.S. Food and Drug Administration - Accessed 2026-09-05

    Scope: identity, clinical, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. Overjet CBCT Assist model card (K251514)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, reportedSensitivity, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. Overjet CBCT Assist: K251514 decision and 510(k) summary

    U.S. Food and Drug Administration - Accessed 2026-09-05

    Scope: identity, clinical, evidence, implementation

  8. Overjet CBCT Assist demo

    Overjet - Accessed 2026-09-05

    Scope: implementation

Research history

  1. K251514 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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