# K180941: Ortho System

- Pathway: 510(k) (Traditional)
- Applicant: 3Shape A/S
- Decided: Oct 17, 2018 after 203 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: 3 generations back to K082207 (2009). 3 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171295: ULab Systems Treatment Planning Software, Ulab Systems, Inc. (2018) Summary page 4.

## Most influential descendants
- K233625: Raydent SW (2024), 2 descendants of its own
- K232564: Align Studio (2024), 1 descendant of its own
- K192244: Arcad SmileStudio and Aligner System (2020), 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

## Indications for use
Ortho System™ for dental retainers and dental cast for sequential aligners is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options based on 3D models of the patient’s dentition before the start of an orthodontic treatment. The use of the Ortho System™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

Source page: https://510kreport.com/device/K180941
Methodology: https://510kreport.com/methodology