# K223518: iOrtho

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai EA Medical Instruments Co., Ltd.
- Decided: Jun 13, 2023 after 202 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.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171634: Ortho System, 3Shape A/S (2018) Summary page 4.

## Most influential descendants
- K232653: Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX (2024), 1 descendant of its own
- K242892: Cristaline Aligners Z FLX (2024), 0 descendants of its own

## Indications for use
iOrtho is intended for use as a medical front-end device providing tools for management of orthodontic cases, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media, Sequential aligners) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of iOrtho 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/K223518
Methodology: https://510kreport.com/methodology