Overjet Charting Assist
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Overjet Charting Assist EUDAMEDFDA UDI
- Generic Name
- Dental x-ray image interpretive software FDA UDI
- Device Name
- Overjet Charting Assist EUDAMED
- Model / Reference
- 1.0 EUDAMEDv1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860005586356 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600055863OJOCHAZ4 EUDAMED
- 510(k) Number
- K241684 FDA 510(k)
- FDA Product Code
- QIH FDA 510(k)FDA UDI
- EMDN Code
- Z12110192 INSTRUMENTS FOR DENTAL TREATMENT UNITS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Dental x-ray image interpretive software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)FDA UDI
- Special Device Type
- Software EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The Overjet Charting Assist is a digital imaging and charting system designed for dental radiography, specifically for capturing and analyzing intraoral radiographs. It integrates with dental imaging workflows to enhance diagnostic accuracy by providing automated measurements and annotations directly on radiographic images, aiding in treatment planning for orthodontic and restorative procedures.
This device is supplied as a software application for use on compatible dental imaging systems, requiring no physical sterilization. It is intended for single-use per patient session, though the underlying hardware may be reusable. The system operates in clinical dental settings and complies with FDA 510(k) clearance under the Radiology advisory committee, with product code QIH. No specific MRI safety or sterility requirements are noted beyond standard software installation guidelines.
Frequently asked questions
What clinical workflows does the Overjet Charting Assist specifically support, and how does it improve diagnostic accuracy?
The Overjet Charting Assist is designed to integrate with dental radiography workflows, particularly for orthodontic and restorative procedures. It enhances diagnostic accuracy by automating measurements and annotations directly on intraoral radiographs, allowing clinicians to streamline treatment planning with precise digital analysis. This eliminates manual calculations and reduces human error, making it ideal for procedures requiring detailed spatial assessments, such as bracket placement or crown preparations.
Is the Overjet Charting Assist a standalone device, or does it require integration with existing dental imaging systems?
The Overjet Charting Assist is a software application that requires integration with compatible dental imaging systems. It does not include physical hardware beyond what is already used for radiography, meaning it relies on existing X-ray or cone-beam CT systems to capture images. The software overlays these images with automated measurements and annotations, making it a supplementary tool rather than a standalone device.
How is the Overjet Charting Assist intended to be used in terms of patient sessions, and does it require sterilization?
The Overjet Charting Assist is intended for single-use per patient session, meaning each new patient interaction should ideally use a fresh instance of the software for accurate and hygienic workflows. Since it is a software application and does not involve physical contact with patients or surfaces, it does not require sterilization. However, the underlying hardware (like sensors or X-ray machines) used to capture images may need standard disinfection procedures as per clinical protocols.
What regulatory pathway was followed for FDA clearance, and what does the product code QIH signify?
The Overjet Charting Assist received FDA clearance through a 510(k) Traditional pathway, specifically under the Radiology (QIH) product code, which categorizes it as a diagnostic radiology device. The Radiology (RA) advisory committee reviewed the submission to determine substantial equivalence to a predicate device. The product code QIH indicates it falls under the broader classification of intraoral imaging devices, aligning with its use for capturing and analyzing intraoral radiographs.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K241684 | Class II | Active |
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Manufacturer
- Manufacturer
- Overjet, Inc.
Sources (3)
- FDA 510(k) K241684 24 fields · synced Sep 18, 2026
- FDA UDI fa6fea25-c29a-4d3c-95e4-f57c7b60d1eb 32 fields · synced May 30, 2026
- EUDAMED 7dd0fd8d-06d3-428d-9d8f-af64650140d7 61 fields · synced Jul 14, 2026