# K211700: EzDent Web

- Pathway: 510(k) (Traditional)
- Applicant: Ewoosoft Co., Ltd.
- Decided: Sep 28, 2021 after 117 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). 14 ancestors in all.
2 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.
- K200178: Ez3D-i /E3, Ewoosoft Co., Ltd. (2020) Summary page 4.

## Most influential descendants
- K230468: EzDent Web (2023), 1 descendant of its own
- K250716: Image One (2025), 0 descendants of its own

## Indications for use
EzDent Web is a dental imaging software that is intended to provide viewer and image processing tools for maxillofacial radiographic images. 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 Web is intended for use as software to acquire, view, and save 2D and 3D image files, to load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment, and to provide 3D visualization and 2D analysis. EzDent Web is not for use for diagnostic purposes.

Source page: https://510kreport.com/device/K211700
Methodology: https://510kreport.com/methodology