Overjet Caries Assist-Pediatric
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233738 FDA 510(k)
- FDA Product Code
- MYN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2070 FDA 510(k)
- Regulation Number
- 892.2070 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Overjet Caries Assist Pediatric is a computer-assisted detection (CADe) software designed for radiological analysis. It automates the detection and segmentation of dental caries on bitewing and periapical radiographs, specifically for pediatric patients aged 4 to 11 years, including both primary and permanent teeth.
This software is intended for concurrent-read use in radiology settings and is supplied as a digital tool requiring compatible imaging systems. It is classified as a Class II medical device under FDA regulations, with a 510(k) clearance through the Radiology Advisory Committee. The device operates as a reusable software solution, with no sterility requirements, and is intended for use within MRI-safe environments.
Frequently asked questions
What is the Overjet Caries Assist-Pediatric specifically designed to analyze in pediatric dental radiographs?
The Overjet Caries Assist-Pediatric is a computer-assisted detection (CADe) software designed to automate the identification and segmentation of dental caries in bitewing and periapical radiographs for children aged 4 to 11. It focuses on both primary and permanent teeth, helping clinicians detect cavities more efficiently during concurrent-read analysis in radiology settings.
How is the Overjet Caries Assist-Pediatric supplied, and what kind of imaging systems does it require?
The Overjet Caries Assist-Pediatric is supplied as a digital software solution, meaning it is not a physical device but rather a reusable tool that integrates with compatible imaging systems. It is intended for use in radiology environments where dental radiographs are already being captured and reviewed.
Does the Overjet Caries Assist-Pediatric have any sterility or single-use requirements, and is it safe for MRI environments?
Since the Overjet Caries Assist-Pediatric is a reusable software solution, there are no sterility requirements or single-use constraints. Additionally, it is designed for use within MRI-safe environments, ensuring compatibility with radiology workflows that include MRI procedures.
What regulatory pathway was followed for the FDA clearance of this device, and which committee was involved?
The Overjet Caries Assist-Pediatric received FDA clearance through a 510(k) submission, classified as a Class II medical device under the Radiology category. The submission was reviewed by the Radiology (RA) Advisory Committee, and the decision was made under the Traditional 510(k) Review pathway, confirming substantial equivalence to a predicate device.
Is this software compatible with specific types of dental imaging equipment, or does it work broadly across different systems?
The Overjet Caries Assist-Pediatric is designed to work with compatible imaging systems used for bitewing and periapical radiographs. While the exact supported systems are not detailed in the data, the software’s compatibility is tied to standard radiology workflows where these types of images are generated, ensuring integration with existing diagnostic equipment.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Overjet Caries Assist-Pediatric Review: Pricing, FDA Status ..., Overjet Caries Assist-Pediatric | FDA Radiology AI Device, Overjet Caries Assist-Pediatric | Overjet, Inc radiology AI profile
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233738 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Overjet, Inc.
Sources (1)
- FDA 510(k) K233738 24 fields · synced Sep 19, 2026