Radiology AI Directory

FDA-cleared profile

Overjet Caries Assist-Pediatric

Overjet, Inc

Aid dentists in detecting and segmenting caries on bitewing and periapical radiographs for patients aged 4-11 with primary or permanent teeth; the output is additional information and does not replace a complete dental review or clinical judgment.

Detection and CADeQuantification 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
Aid dentists in detecting and segmenting caries on bitewing and periapical radiographs for patients aged 4-11 with primary or permanent teeth; the output is additional information and does not replace a complete dental review or clinical judgment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Dentists and dental clinicians; the FDA packet emphasizes the dentist's complete review and clinical judgment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Dental clinic or dental-office workflow; the FDA device description says images are pulled from a clinic or dental office but does not establish a broader facility setting.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Concurrent-read CADe detection and segmentation adjunct that presents editable polygon annotations for suspected caries to clinician reviewers.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Bitewing and periapical radiographs from patients aged 4-11 with primary or permanent teeth, including primary or mixed dentition, who are indicated for dental radiographs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Polygon annotations for suspected caries at the tooth surface or tooth level; annotations can be adjusted, hidden, deleted, and viewed with or without a color fill.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Not a replacement for a dentist's complete review or clinical judgment and not for standalone patient-management decisions. The labeled scope is limited to bitewing and periapical radiographs and patients aged 4-11 with primary or permanent teeth; FDA testing covered 1,190 standalone images and a 636-image reader study, so performance outside the tested image and sensor populations requires confirmation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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
K233738
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Dental/Maxillofacial (carious tooth surfaces)
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-03-04
  • 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
Software-only three-layer Network, Presentation, and Decision architecture; images are pulled from a clinic or dental office and predictions are pushed to a dashboard. The FDA packet does not establish DICOM, PACS, RIS, EHR, or a specific deployment model.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
On-premise
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Overjet Caries Assist-Pediatric; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-08
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
FDA K233738 reports a fully crossed MRMC reader-improvement study with 20 US licensed dentists, 636 images, and a consensus reference standard from three general dentists. Average wAFROC improvement was 7.5% with reported 95% CI (0.062, 0.088), and average tooth-level sensitivity increased 11.8% with a slight specificity decrease. Standalone testing used 1,190 bitewing and periapical images with a three-dentist consensus standard: tooth-level sensitivity 83.9% (95% CI 81.6%-86.0%), specificity 97.5% (95% CI 97.1%-97.9%), and mean Dice 79.0% (95% CI 78.4%-79.7%).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
83.9%, 95% CI: 81.6%, 86.0%
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

Reported specificity
97.5%, 95% CI: 97.1%, 97.9%
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Overjet Caries Assist-Pediatric regulatory performance study summary

  • DesignStand-alone performance and reader study (ACR AI Central category)
  • PopulationPediatric
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K233738
  • Samplen=1190
  • IndependenceIndependence not established

K233738

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

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 2026-09-08

No public price or quote for the exact K233738 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

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
The exact-identifier FDA recall query returned no native recall record for K233738. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-08

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.

Exact FDA record reviewedStatus
2026-09-08Last searched
23Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, acr ai central product, fda device recall, literature index, trial registry, 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. FDA K233738: Overjet Caries Assist-Pediatric

    U.S. Food and Drug Administration - Published 2024-03-04 - Accessed 2026-09-08

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Overjet Caries Assist-Pediatric model card (K233738)

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

    Scope: intendedUsers, careSetting, output, reportedSensitivity, reportedSpecificity, evidenceSummary, anatomy, evidenceStudies

  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. openFDA exact recall query for K233738

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K233738 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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