# K171122: CEREC Ortho Software

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Jan 11, 2018 after 269 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: 2 generations back to K082207 (2009). 2 ancestors in all.
5 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)
- K152086: 3Shape Ortho System, 3Shape A/S (2016) Summary page 4.

## Most influential descendants
- K233625: Raydent SW (2024), 2 descendants of its own
- K232564: Align Studio (2024), 1 descendant of its own
- K260419: LingOral Dental Design System (2026), 0 descendants of its own
- K253343: Celebrace Software (2025), 0 descendants of its own
- K250198: Laon Ortho (2025), 0 descendants of its own

## Indications for use
CEREC Ortho Software is intended for use with image data acquired from handheld intra oral 3D cameras and desktop laboratory scanners to create 3D virtual models to be used for data acquisition and modeling analysis for orthodontic patients and conditions. The CEREC Ortho Software 3D model data can be exported to orthodontic design software to aid in the design of orthodontic appliances.

Source page: https://510kreport.com/device/K171122
Methodology: https://510kreport.com/methodology