# Ewoosoft Co., Ltd.

- Location (FDA's records): Hwaseong-Si, KR
- FDA decisions: 31 (2013–2025): 31 510(k) clearances
- Product codes: LLZ (29), QIH (2)
- 510(k) review time since 2016: median 50 days, against 115 for FDA's reviews in the same codes and years (22 of 27 faster)
- Predicates its devices cite: 32 (27 its own); citations of its devices by later devices: 34 (27 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cybermed, Inc.: 2 (https://510kreport.com/company/cybermed)
- LK Consulting Group USA, Inc.: 1 (https://510kreport.com/company/lk-consulting-group-usa)
- Carestream Dental, LLC: 1 (https://510kreport.com/company/carestream-dental)
- Gendex Dental Systems: 1 (https://510kreport.com/company/gendex-dental-systems)

## Firms that cite its devices most
- Denti.Ai Technology, Inc.: 1 (https://510kreport.com/company/denti-ai-technology)
- Infomed Software, S.L.: 1 (https://510kreport.com/company/infomed-software)
- Assemblecircle Corp.: 1 (https://510kreport.com/company/assemblecircle)
- Dgnct, LLC: 1 (https://510kreport.com/company/dgnct)
- LK Consulting Group USA, Inc.: 1 (https://510kreport.com/company/lk-consulting-group-usa)
- 3D Industrial Imaging Co., Ltd.: 1 (https://510kreport.com/company/3d-industrial-imaging)
- Overjet, Inc.: 1 (https://510kreport.com/company/overjet)

## Its most-cited devices
- K192888: EzOrtho (2020), cited by 3
- K202116: EzDent-i/ E2/ Prora View/ Smart M Viewer (2020), cited by 2
- K231757: Ez3D-i /E3 (2023), cited by 2
- K211791: Ez3D-i/E3 (2021), cited by 2
- K200178: Ez3D-i /E3 (2020), cited by 2
- K211700: EzDent Web (2021), cited by 1

## Recent decisions
- K250005: Clever One (May 23, 2025)
- K241114: EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) (Jul 23, 2024)
- K231757: Ez3D-i /E3 (Jul 14, 2023)
- K230468: EzDent Web (Apr 21, 2023)
- K223820: EzDent-i / E2 / Prora View/ Smart M Viewer (Feb 17, 2023)
- K222069: Ez3D-i/E3 (Sep 6, 2022)
- K222145: EzDent-i / E2 / Prora View/ Smart M Viewer (Aug 12, 2022)
- K220003: EzOrtho v1.3 (Feb 23, 2022)

Source page: https://510kreport.com/company/ewoosoft