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Ewoosoft Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
31
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250005Clever OneMay 23, 2025
K241114EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)July 23, 2024
K231757Ez3D-i /E3July 14, 2023
K230468EzDent WebApril 21, 2023
K223820EzDent-i / E2 / Prora View/ Smart M ViewerFebruary 17, 2023
K222069Ez3D-i/E3September 6, 2022
K222145EzDent-i / E2 / Prora View/ Smart M ViewerAugust 12, 2022
K220003EzOrtho v1.3February 23, 2022
K211795EzDent-i/ E2/ Prora View/ Smart M ViewerOctober 4, 2021
K211700EzDent WebSeptember 28, 2021
K211793EzOrthoAugust 23, 2021
K211791Ez3D-i/E3August 20, 2021
K202948EzOrthoOctober 22, 2020
K202116EzDent-i/ E2/ Prora View/ Smart M ViewerAugust 21, 2020
K192888EzOrthoMarch 13, 2020
K200178Ez3D-i /E3February 25, 2020
K192098EzMobileJanuary 20, 2020
K190791Ez3D-i/E3April 19, 2019
K190087EzDent-i / E2 / Prora ViewFebruary 27, 2019
K173863Ez3D-i /E3February 23, 2018