# K233625: Raydent SW

- Pathway: 510(k) (Traditional)
- Applicant: Ray Co., Ltd.
- Decided: May 16, 2024 after 185 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: 4 generations back to K082207 (2009). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180941: Ortho System, 3Shape A/S (2018) Summary page 6.
- K171122: CEREC Ortho Software, Dentsply Sirona (2018) Summary page 6.

## Most influential descendants
- K260419: LingOral Dental Design System (2026), 0 descendants of its own
- K253343: Celebrace Software (2025), 0 descendants of its own

## Indications for use
RAYDENT SW 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 prosthetic devices (Veneer, Crown, Bridge, In/Onlay) and orthodontic devices (Clear Aligner). To use RAYDENT SW, users must have the necessary education and domain knowledge in orthodontic or prosthodontic practice and receive dedicated training in the use of the software.

Source page: https://510kreport.com/device/K233625
Methodology: https://510kreport.com/methodology