Class Class II
EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) (K241114)
Description
EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) by Ewoosoft Co., Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241114
Clearance Date2024-07-23
Clearance TypeSpecial
Product CodeLLZ
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241114
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) (K241114) cites 1 predicate device and is itself cited by 4 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223820 | EzDent-i / E2 / Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2023 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250005 | Clever One | Ewoosoft Co., Ltd. | 2025 |
| K243088 | Green X 12 SE (PHT-40CHS) | VATECH Co., Ltd. | 2025 |
| K243081 | Green X 21 (PHT-90CHO) | VATECH Co., Ltd. | 2025 |
| K242778 | X Sensor (Model: IOS-A15IF, HDI-15DGF) | Qpix Solutions, Inc. | 2024 |
Trace the full predicate network for K241114
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.