Overjet Caries Assist-Pediatric

by Overjet  · Based in United States → — The #1 Dental AI Platform for Providers & Payers
Dentistry Pediatrics
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Subscription-based
Regulatory Status Disclosed

Overview

Overjet Caries Assist-Pediatric (OCA-Ped) is an FDA-cleared, radiological, automated, concurrent-read, computer-assisted detection (CADe) software designed to aid in the detection and segmentation of caries on bitewing and periapical radiographs for pediatric patients. Specifically, it is intended for use with patients aged 4-11, covering both primary and permanent teeth (primary or mixed dentition). This AI tool provides additional information for dentists to use in their diagnosis of tooth surfaces suspected of being carious, enhancing diagnostic accuracy. It is not intended as a replacement for a complete dentist’s review or their clinical judgment. Overjet Caries Assist-Pediatric also helps improve patient (parent) understanding and case acceptance through visual explanations, such as color-coded overlays on X-rays.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered caries detection and outlining for pediatric patients (ages 4+)
  • Segmentation of dental structures (enamel, pulp, crowns, fillings) for ages 5+
  • Enhanced diagnostic accuracy for subtle oral diseases
  • Patient education tools with color-coded overlays on X-rays
  • Integration with existing dental practice management and imaging systems
  • AI-powered dashboards for preventive dentistry and treatment planning
  • Automated administrative tasks (e.g., coding/billing errors, insurance verification)
  • Image enhancement for clearer X-ray results

Use Cases

  • Early detection and quantification of pediatric caries
  • Improving parent understanding and case acceptance for recommended treatments
  • Standardizing care and tracking clinical metrics across practices
  • Facilitating preventive dentistry planning based on patient history
  • Streamlining diagnostic workflows for dental professionals

What Physicians Need to Know

Dental X-Ray Analysis
Overjet Caries Assist-Pediatric is an FDA-cleared radiological, automated, computer-assisted detection (CADe) software designed to aid in the detection and segmentation of caries on bitewing and periapical radiographs for patients aged 4-11. It analyzes both primary and permanent teeth and provides additional information for the dentist's diagnosis, not replacing clinical judgment. The tool highlights findings with colorful outlines to enhance understanding for both children and parents. A 'Charting Assist' feature also detects dental structures like enamel, pulp, crowns, and fillings in patients ages 5 and above.
Caries Detection Accuracy
In a rigorous clinical study for the FDA, 100% of dentists demonstrated improved accuracy in detecting cavities when using Overjet for Kids compared to their evaluations without it, missing 57% fewer cavities. The standalone tooth-level sensitivity was 83.9% and specificity was 97.5% for bitewing and periapical images in the 4-11 age group. Assisted readers showed a 7.5% improvement in detection performance and an 11.8% increase in average tooth-level sensitivity compared to unassisted readers. The algorithm is effective in identifying early caries and incipient lesions.
Treatment Planning AI
The AI platform supports smarter treatment planning by offering data-driven insights and helping identify necessary treatments based on previous images and practice management system (PMS) data. AI-powered dashboards assist dental teams in preparing for patient visits by highlighting future treatment needs and supporting early intervention.
Dental Imaging Integration (CBCT/Panoramic)
Overjet AI integrates with existing dental imaging systems. When embedded in platforms like Oryx Imaging, AI insights appear instantly on bitewings, periapical radiographs, and panoramic images, streamlining the radiographic workflow.
Practice Management Integration
Overjet's AI platform is designed to integrate with most practice management systems (PMS). This integration allows for the utilization of patient data to optimize workflows, enhance treatment planning, and improve overall practice efficiency.
Patient Communication Tools
Overjet for Kids significantly enhances patient (parent) education by transforming traditional X-rays with clear, color-coded overlays that visually explain diagnoses. This visual communication tool helps parents better understand recommendations and has been shown to increase overall case acceptance by an average of 25%.
Insurance Pre-Authorization
The AI tool streamlines the insurance approval process by providing AI-supported evidence and consistent documentation. It assists with pre-authorizations by combining AI-analyzed clinical findings with annotated radiographs and clear documentation, leading to faster approvals and stronger justification for treatment plans. Practices using Overjet have reported faster pre-approval turnaround times and a reduction in claim denials.
Physician Tip

Leverage the visual overlays to educate parents and children directly from the X-rays, fostering trust and improving understanding of diagnoses and treatment plans. Utilize the AI's early detection capabilities to implement preventive strategies, potentially reducing the need for more extensive interventions later. Integrate the AI insights into your existing workflow for consistent diagnostic support and to streamline documentation for insurance submissions.

Overjet Caries Assist-Pediatric, as part of the broader Overjet AI platform, is designed for seamless integration with various dental imaging systems and most practice management systems (PMS). This allows for real-time analysis of radiographs (bitewings, periapicals, and panos) and the incorporation of AI-driven insights directly into patient records and treatment planning workflows. The integration aims to enhance diagnostic consistency, documentation accuracy, and overall practice efficiency.

Details

Category Dental AI
Pricing Subscription-based
  • Subscription-based; $1000-$2000/month (smaller practices); higher for larger practices with advanced features
DeploymentCloud-based
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

FDA 510(k) clearance K233738 was received on March 4, 2024, for Overjet Caries Assist-Pediatric. It is cleared to aid in the detection and segmentation of caries on bitewing and periapical radiographs for patients aged 4-11 with primary or mixed dentition.
Integrations
EHR Not specified
Specialties Dentistry, Pediatrics

What the Web Says

Overjet Caries Assist-Pediatric is an AI-powered dental software cleared by the FDA to detect, outline, and quantify tooth decay in children aged 4 and above. It aims to improve diagnostic accuracy for pediatric dentists and enhance patient (parent) understanding of oral health through visual aids. The technology has shown to increase cavity detection rates and improve case acceptance in dental practices.

Overall: Mixed

Strengths

  • Improved accuracy in detecting pediatric caries, with dentists being 100% more accurate in clinical studies when using the AI.
  • Ability to precisely outline and quantify caries, allowing dentists to monitor changes over time.
  • Enhances patient education and trust, as parents can visually understand the issues on X-rays.
  • Early detection of cavities, potentially allowing for habit changes before irreversible work is needed.
  • Can act as a reliable 'second set of eyes' for dentists, catching things that might be missed during busy periods.
  • Streamlines workflow and can save time on documentation with features like Voice AI.

Limitations

  • Some users report the software can be glitchy.
  • Potential for false positives and false negatives, which can undermine a dentist's diagnosis if shown to patients without careful review.
  • Concerns about inconsistent billing and poor customer service from some users.
  • One user reported a data confidentiality violation where they saw patient data from an unrelated office.
  • The product is not 100% sensitive and may miss some caries, potentially delaying necessary treatment.
  • The company also sells its AI to dental insurers, which some providers find problematic due to increased AI-driven denials and administrative burden.

Based on reviews from: Overjet.ai, PMC, The Molar Report, Becker's Dental Review, Reddit, Dental Products Report, accessdata.fda.gov, Capterra

Last updated: 2026-07-21

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Press & Coverage

American College of Radiology
AI Central Market Updates for May 15, 2024
Overjet Caries Assist-Pediatric (OCA-Ped) was added to the ACR's AI Central directory, indicating its recent FDA 510(k) clearance. The software is designed to aid in the detection and segmentation of caries on bitewing and periapical radiographs for patients aged 4-11 years old.
2024-05
accessdata.fda.gov
510(k) Premarket Notification K233738
This FDA document details the 510(k) clearance for Overjet Caries Assist-Pediatric (OCA-Ped), an automated, computer-assisted detection software for caries on dental radiographs in pediatric patients. The clearance was granted on March 4, 2024.
2024-03
Innolitics
Overjet Caries Assist-Pediatric (K233738) u2014 FDA 510(k)
Innolitics provides an overview of the FDA 510(k) clearance for Overjet Caries Assist-Pediatric (OCA-Ped), highlighting its function as a radiological, automated, computer-assisted detection software. The article also mentions its intended use for caries detection on bitewing and periapical radiographs.
2024-03
Odontologos.com
FDA-Approved AI Solutions in Dental Imaging: A Narrative Review of Applications, Evidence, and Outlook
This narrative review discusses FDA-approved AI platforms in dental imaging, including Overjet Caries Assist-Pediatric, which is approved for use in pediatric patients aged 4-11. It emphasizes FDA clearance as a benchmark for safety and effectiveness.
2026-02
PMC (PubMed Central)
FDA-Approved AI Solutions in Dental Imaging: A Narrative Review of Applications, Evidence, and Outlook
This review article, also found on PubMed Central, confirms that Overjet Caries Assist-Pediatric is among the FDA-cleared AI platforms for dental imaging, specifically approved for pediatric patients (ages 4-11). It details the regulatory pathways and performance outcomes of various AI tools.
2025-12
MDPI
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting
This publication lists Overjet Caries Assist-Pediatric (K233738) as an FDA-authorized machine learning-enabled medical device in 2024, cleared via the 510(k) pathway for dental caries detection in pediatric patients. It also provides performance metrics like sensitivity and specificity.
2025-12
FDA
TPLC - Total Product Life Cycle
The FDA's Total Product Life Cycle database entry for Overjet, Inc. lists 'Overjet Caries Assist-Pediatric' (K233738) as one of their substantially equivalent devices, categorized as a Class 2 medical image analyzer.
2026-07
Compendium of Continuing Education in Dentistry (CDEWorld)
Optimizing Dental Practice Performance Through Artificial Intelligence: Enhancing Patient Safety, Scheduling, Operations, Marketing, and Financial Management
This article highlights FDA-cleared tools like Overjet Caries Assist-Pediatric (FDA 510[k] number K233738) as examples of AI-assisted diagnostics that improve patient safety and diagnostic accuracy in dentistry.
2026-03

Videos

Product demos, reviews, and walkthroughs for Overjet Caries Assist-Pediatric.

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Frequently Asked Questions

Overjet Caries Assist-Pediatric (OCA-Ped) is an FDA-cleared, AI-powered software designed to aid in the detection and segmentation of caries on bitewing and periapical radiographs for patients aged 4-11. It integrates with existing digital imaging and practice management systems, providing dentists with color-coded outlines on X-rays to enhance diagnostic accuracy and facilitate patient and parent education.
Yes, Overjet Caries Assist-Pediatric is FDA-cleared for detecting, outlining, and quantifying tooth decay in children ages 4 and above, covering both primary and permanent teeth. Overjet also adheres to stringent data security and privacy standards, including HIPAA, GDPR, and CCPA, ensuring patient data is protected.
Overjet Caries Assist-Pediatric significantly enhances traditional visual and radiographic methods by providing an objective, AI-driven analysis that can detect subtle decay often missed by the unaided eye. In clinical studies, dentists were more accurate in detecting cavities when using Overjet for Kids, and it is uniquely cleared to precisely outline and quantify caries.
Overjet typically offers a subscription-based pricing model, with costs varying based on the size of the dental practice and the specific features or integrations chosen. Smaller practices might anticipate a starting price in the range of $1,000 to $2,000 per month, with larger practices potentially incurring higher costs for advanced functionalities.
Overjet Caries Assist-Pediatric is intended as an aid to diagnosis and not a replacement for a complete dentist's review or their clinical judgment, which should always incorporate other relevant patient information. The accuracy of the AI analysis is also highly dependent on the quality of the initial dental radiographs.
Overjet prioritizes data security and is a HIPAA-ready solution, ensuring high levels of data security, integrity, and encryption for Protected Health Information (PHI). The company conducts regular security risk evaluations, deploys patches, and undergoes independent third-party audits to maintain compliance and protect customer data.
Initial setup and training are necessary to seamlessly integrate Overjet Caries Assist-Pediatric into existing dental practice systems and to ensure staff proficiency. While some time investment is required for integration and training, the platform is designed to simplify administrative tasks and enhance workflow efficiency.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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