Celebrace Software is a dental software tool that assists orthodontists in planning patient treatments and designing orthodontic devices such as wires, brackets, and bonding trays. It uses patient images, including 3D mesh data derived from scans and CBCT radiographs, to generate treatment plans and device designs that help clinicians provide precise orthodontic care.
Intended Use
Celebrace software is designed to assist dental professionals in planning patient treatment and designing orthodontic devices based on 3D mesh data and patient images.
Technology
Software inputs include intraoral scans, CBCT radiographs, and patient demographics. It creates orthodontic treatment plans and generates device design files for manufacturing orthodontic wires, brackets and bonding trays using a static algorithm locked at release. Tooth segmentation is performed by a separately cleared software.
Performance
The software passed verification and validation testing and performed as intended. Software documentation followed FDA and IEC guidance standards. Testing confirmed safety and effectiveness comparable to predicate device Raydent Software (K233625).
Predicate Devices
No predicate devices specified
Ready to Sharpen Your Edge?
Subscribe to join 8,500+ peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.