# K202116: EzDent-i/ E2/ Prora View/ Smart M Viewer

- Pathway: 510(k) (Special)
- Applicant: Ewoosoft Co., Ltd.
- Decided: Aug 21, 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: 11 generations back to K930527 (1993). 11 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190087: EzDent-i / E2 / Prora View, Ewoosoft Co., Ltd. (2019) Summary page 5.

## Most influential descendants
- K211795: EzDent-i/ E2/ Prora View/ Smart M Viewer (2021), 4 descendants of its own
- 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
- K211700: EzDent Web (2021), 2 descendants of its own
- K241114: EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) (2024), 1 descendant 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/K202116
Methodology: https://510kreport.com/methodology