# K253343: Celebrace Software

- Pathway: 510(k) (Traditional)
- Applicant: Celebrace
- Decided: Dec 29, 2025 after 90 days
- Product code: PNN (Orthodontic Software)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K082207 (2009). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233625: Raydent SW, Ray Co., Ltd. (2024) Summary page 6.
- K232429: Titan Dental Design, Clearadvance, LLC (2023)
- K203442: Inbrace Orthodontic System, Swift Health Systems, Inc. (2021)

## Indications for use
Celebrace software is a software designed to assist dental professionals in planning patient treatment and designing treatment devices. The software performs simulations based on patient images, allowing reference to treatment plans, and is used as a tool to design treatment devices based on 3D mesh data. Treatment devices include orthodontic devices (orthodontic wires, orthodontic brackets and bonding trays). To use Celebrace Software, users must have the necessary education and domain knowledge in orthodontic practice and receive dedicated training in the use of the software.

Source page: https://510kreport.com/device/K253343
Methodology: https://510kreport.com/methodology