Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Ewoosoft Co., Ltd. — Predicate Candidate Screening
31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
117 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250005 | Clever One | Ewoosoft Co., Ltd. | 2025-05-23 | 141 | 0 |
| K241114 | EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) | Ewoosoft Co., Ltd. | 2024-07-23 | 92 | 0 |
| K231757 | Ez3D-i /E3 | Ewoosoft Co., Ltd. | 2023-07-14 | 28 | 0 |
| K230468 | EzDent Web | Ewoosoft Co., Ltd. | 2023-04-21 | 59 | 0 |
| K223820 | EzDent-i / E2 / Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2023-02-17 | 58 | 0 |
| K222069 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2022-09-06 | 54 | 0 |
| K222145 | EzDent-i / E2 / Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2022-08-12 | 23 | 0 |
| K220003 | EzOrtho v1.3 | Ewoosoft Co., Ltd. | 2022-02-23 | 50 | 0 |
| K211795 | EzDent-i/ E2/ Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2021-10-04 | 116 | 0 |
| K211700 | EzDent Web | Ewoosoft Co., Ltd. | 2021-09-28 | 117 | 0 |
| K211793 | EzOrtho | Ewoosoft Co., Ltd. | 2021-08-23 | 74 | 0 |
| K211791 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2021-08-20 | 71 | 0 |
| K202948 | EzOrtho | Ewoosoft Co., Ltd. | 2020-10-22 | 22 | 0 |
| K202116 | EzDent-i/ E2/ Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2020-08-21 | 22 | 0 |
| K192888 | EzOrtho | Ewoosoft Co., Ltd. | 2020-03-13 | 155 | 0 |
| K200178 | Ez3D-i /E3 | Ewoosoft Co., Ltd. | 2020-02-25 | 32 | 0 |
| K192098 | EzMobile | Ewoosoft Co., Ltd. | 2020-01-20 | 168 | 0 |
| K190791 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2019-04-19 | 23 | 0 |
| K190087 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2019-02-27 | 41 | 0 |
| K173863 | Ez3D-i /E3 | Ewoosoft Co., Ltd. | 2018-02-23 | 65 | 0 |
| K173094 | OrthoVision | Ewoosoft Co., Ltd. | 2017-10-26 | 27 | 0 |
| K172364 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2017-08-22 | 18 | 0 |
| K163533 | EzDent-i; E2; ProraView | Ewoosoft Co., Ltd. | 2017-01-12 | 27 | 0 |
| K163539 | Ez3D-i / E3 | Ewoosoft Co., Ltd. | 2016-12-23 | 7 | 0 |
| K161246 | Ez3D-i / E3 | Ewoosoft Co., Ltd. | 2016-05-31 | 28 | 0 |
| K161117 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2016-05-13 | 23 | 0 |
| K152746 | Ez3D Plus | Ewoosoft Co., Ltd. | 2016-01-03 | 102 | 0 |
| K150761 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2015-06-05 | 74 | 0 |
| K131594 | EZDENTI-I; E2; PRORA VIEW | Ewoosoft Co., Ltd. | 2013-08-29 | 87 | 0 |
| K131616 | EZ3D-I, E3 | Ewoosoft Co., Ltd. | 2013-08-29 | 87 | 0 |
| K131570 | ORTHOVISION | Ewoosoft Co., Ltd. | 2013-08-15 | 77 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda