Company ยท KR
Ewoosoft Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2025. Name variants (Inc, Corp, punctuation) are merged.
31510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 23, 2025 | K250005 | Clever One Ewoosoft Co., Ltd., KR | QIH |
| Jul 23, 2024 | K241114 | EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) Ewoosoft Co., Ltd., KR | LLZ |
| Jul 14, 2023 | K231757 | Ez3D-i /E3 Ewoosoft Co., Ltd., KR | QIH |
| Apr 21, 2023 | K230468 | EzDent Web Ewoosoft Co., Ltd., KR | LLZ |
| Feb 17, 2023 | K223820 | EzDent-i / E2 / Prora View/ Smart M Viewer Ewoosoft Co., Ltd., KR | LLZ |
| Sep 6, 2022 | K222069 | Ez3D-i/E3 Ewoosoft Co., Ltd., KR | LLZ |
| Aug 12, 2022 | K222145 | EzDent-i / E2 / Prora View/ Smart M Viewer Ewoosoft Co., Ltd., KR | LLZ |
| Feb 23, 2022 | K220003 | EzOrtho v1.3 Ewoosoft Co., Ltd., KR | LLZ |
| Oct 4, 2021 | K211795 | EzDent-i/ E2/ Prora View/ Smart M Viewer Ewoosoft Co., Ltd., KR | LLZ |
| Sep 28, 2021 | K211700 | EzDent Web Ewoosoft Co., Ltd., KR | LLZ |
| Aug 23, 2021 | K211793 | EzOrtho Ewoosoft Co., Ltd., KR | LLZ |
| Aug 20, 2021 | K211791 | Ez3D-i/E3 Ewoosoft Co., Ltd., KR | LLZ |
| Oct 22, 2020 | K202948 | EzOrtho Ewoosoft Co., Ltd., KR | LLZ |
| Aug 21, 2020 | K202116 | EzDent-i/ E2/ Prora View/ Smart M Viewer Ewoosoft Co., Ltd., KR | LLZ |
| Mar 13, 2020 | K192888 | EzOrtho Ewoosoft Co., Ltd., KR | LLZ |
| Feb 25, 2020 | K200178 | Ez3D-i /E3 Ewoosoft Co., Ltd., KR | LLZ |
| Jan 20, 2020 | K192098 | EzMobile Ewoosoft Co., Ltd., KR | LLZ |
| Apr 19, 2019 | K190791 | Ez3D-i/E3 Ewoosoft Co., Ltd., KR | LLZ |
| Feb 27, 2019 | K190087 | EzDent-i / E2 / Prora View Ewoosoft Co., Ltd., KR | LLZ |
| Feb 23, 2018 | K173863 | Ez3D-i /E3 Ewoosoft Co., Ltd., KR | LLZ |
| Oct 26, 2017 | K173094 | OrthoVision Ewoosoft Co., Ltd., KR | LLZ |
| Aug 22, 2017 | K172364 | EzDent-i / E2 / Prora View Ewoosoft Co., Ltd., KR | LLZ |
| Jan 12, 2017 | K163533 | EzDent-i; E2; ProraView Ewoosoft Co., Ltd., KR | LLZ |
| Dec 23, 2016 | K163539 | Ez3D-i / E3 Ewoosoft Co., Ltd., KR | LLZ |
| May 31, 2016 | K161246 | Ez3D-i / E3 Ewoosoft Co., Ltd., KR | LLZ |
| May 13, 2016 | K161117 | EzDent-i / E2 / Prora View Ewoosoft Co., Ltd., KR | LLZ |
| Jan 3, 2016 | K152746 | Ez3D Plus Ewoosoft Co., Ltd., KR | LLZ |
| Jun 5, 2015 | K150761 | Ez3D-i/E3 Ewoosoft Co., Ltd., KR | LLZ |
| Aug 29, 2013 | K131616 | EZ3D-I, E3 Ewoosoft Co., Ltd. | LLZ |
| Aug 29, 2013 | K131594 | EZDENTI-I; E2; PRORA VIEW Ewoosoft Co., Ltd. | LLZ |
| Aug 15, 2013 | K131570 | ORTHOVISION Ewoosoft Co., Ltd. | LLZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||