# K202948: EzOrtho

- Pathway: 510(k) (Special)
- Applicant: Ewoosoft Co., Ltd.
- Decided: Oct 22, 2020 after 22 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K930527 (1993). 9 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192888: EzOrtho, Ewoosoft Co., Ltd. (2020) Summary page 5.

## Most influential descendants
- K211793: EzOrtho (2021), 5 descendants of its own
- K220003: EzOrtho v1.3 (2022), 4 descendants of its own
- K222054: Denti.AI Auto-Chart (2022), 3 descendants of its own
- K233590: Overjet Charting Assist (2024), 2 descendants of its own
- K241684: Overjet Charting Assist (2024), 1 descendant of its own

## Indications for use
EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists.

Source page: https://510kreport.com/device/K202948
Methodology: https://510kreport.com/methodology