# K232564: Align Studio

- Pathway: 510(k) (Traditional)
- Applicant: Laon Medi, Inc.
- Decided: Mar 12, 2024 after 201 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.
1 later device descends from it; 1 cites it directly.
0 of 7 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
- K250198: Laon Ortho (2025), 0 descendants of its own

## Indications for use
The Align Studio 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 3Dmodels of the patient’s dentition before the start of an orthodontic treatment. The use of the Align Studio 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/K232564
Methodology: https://510kreport.com/methodology