# K241114: EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)

- Pathway: 510(k) (Special)
- Applicant: Ewoosoft Co., Ltd.
- Decided: Jul 23, 2024 after 92 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: 15 generations back to K930527 (1993). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223820: EzDent-i / E2 / Prora View/ Smart M Viewer, Ewoosoft Co., Ltd. (2023) Summary page 4.

## Most influential descendants
- K250005: Clever One (2025), 0 descendants of its own

## Indications for use
EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.

Source page: https://510kreport.com/device/K241114
Methodology: https://510kreport.com/methodology