CEPHX3D
510(k) K252538
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK252538 | Date5 Mar 2026 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- QIH
- FDA applicant
- Orca Dental AI , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
CephX3D is an automated radiological image processing software designed for orthodontic cephalometric analysis. It processes digital radiographic images to generate diagnostic reports, treatment plans, and predictive analyses, leveraging AI-driven algorithms to enhance clinical decision-making in orthodontics. The device falls under the category of radiology software, specifically tailored for cephalometric imaging evaluation.
CephX3D is supplied as a software solution for use in dental clinics and orthodontic practices, requiring integration with compatible radiographic imaging systems. It is intended for single-use per diagnostic session, though the software itself may be reused across multiple cases. The device operates in non-sterile environments and does not require sterilization. Authorized for use in the United States under FDA 510(k) clearance (K252538), it adheres to regulatory standards for radiology software in orthodontic diagnostics.
Other devices from Orca Dental AI, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is CephX3D used for in orthodontics?
CephX3D is an automated radiological image processing software designed specifically for orthodontic cephalometric analysis. It processes digital radiographic images to produce detailed diagnostic reports, personalized treatment plans, and predictive analyses. By leveraging AI-driven algorithms, it enhances clinical decision-making by streamlining the interpretation of cephalometric data, reducing human error, and accelerating workflow efficiency.
How is CephX3D supplied and where can it be used?
CephX3D is supplied as a software solution intended for integration with compatible radiographic imaging systems in dental clinics and orthodontic practices. It operates in non-sterile environments, meaning it does not require sterilization or specialized handling beyond standard IT and software installation protocols. The software itself is reusable across multiple diagnostic sessions, though each analysis session is treated as a single-use case for clinical purposes.
Is CephX3D single-use or reusable, and does it need sterilization?
CephX3D is designed for single-use per diagnostic session in terms of generating reports and analyses, but the software itself is reusable across different patients. Since it operates in a non-sterile environment and does not involve physical patient contact or reusable hardware components, sterilization is not required. The software’s functionality relies entirely on digital processing, eliminating the need for sterilization procedures.
What regulatory approval does CephX3D have, and where is it authorized?
CephX3D has received FDA 510(k) clearance under the reference number K252538, confirming it is substantially equivalent to a legally marketed predicate device. This approval authorizes its use in the United States for automated cephalometric analysis in orthodontics. The software adheres to regulatory standards for radiology software, ensuring compliance with safety and effectiveness requirements for diagnostic tools in dental and orthodontic settings.
Does CephX3D require integration with specific radiographic imaging systems?
Yes, CephX3D is designed to integrate with compatible radiographic imaging systems to process digital radiographs. The software is tailored for use with systems that output digital cephalometric images, enabling seamless analysis and report generation. Compatibility details are typically outlined in the software’s technical specifications or user manual, which should be consulted during installation to ensure proper integration with existing equipment.