Celebrace Software

Celebrace Software is an orthodontic treatment planning tool that assists dental professionals in designing customized orthodontic treatment devices. It accepts intraoral scans, CBCT radiographs, and patient demographics as inputs, then generates treatment plans and manufacturing files for orthodontic wires, brackets, and bonding trays. Users must have orthodontic training and education to operate the software.

Celebrace software uses a static, locked algorithm to generate 2D and 3D treatment device designs, whereas predicate devices output only 3D designs. Unlike predicates, Celebrace does not design prosthetics and does not perform tooth segmentation internally—segmentation is performed by a separate 510(k)-cleared software. Operating environment and hardware requirements differ from predicates but do not impact intended use.

Software documentation was prepared per FDA Guidance Document 'Content of Premarket Submissions for Device Software Functions' (June 14, 2023) and ANSI/AAMI/IEC 62304: Medical Device Software—Software life cycle processes.

The subject device has passed performance testing and software validation demonstrating it performs per intended use and is as safe and effective as the predicate device Raydent SW (K233625). Design, construction, and performance characteristics are similar to predicates. Identified differences—lack of prosthetic design, outsourced segmentation, and OS/hardware variations—are not substantial and do not impact efficacy or introduce new risks.