# K211795: EzDent-i/ E2/ Prora View/ Smart M Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Ewoosoft Co., Ltd.
- Decided: Oct 4, 2021 after 116 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: 12 generations back to K930527 (1993). 12 ancestors in all.
4 later devices descend 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)
- K202116: EzDent-i/ E2/ Prora View/ Smart M Viewer, Ewoosoft Co., Ltd. (2020) Summary page 4.

## Most influential descendants
- K222145: EzDent-i / E2 / Prora View/ Smart M Viewer (2022), 3 descendants of its own
- K223820: EzDent-i / E2 / Prora View/ Smart M Viewer (2023), 2 descendants of its own
- K241114: EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) (2024), 1 descendant of its own
- 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/K211795
Methodology: https://510kreport.com/methodology