510(k) · Cleared
ClearedEzDent Web
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ewoosoft Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Apr 21, 2023 as substantially equivalent to K211700 (Ewoosoft Co., Ltd., 2021) after a 59-day review. Its family tree reaches back 13 generations to 1993. 1 later device descends from it.
- Decided
- Apr 21, 2023
- Review
- 59 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K930527 (1993). 15 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK930527 Dental LinkEscan, Inc. · 1993
- 9 generations between
- 3 generations backK190087 EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2019
- 2 generations backK202116 EzDent-i/ E2/ Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2020
- 1 generation backK211700 EzDent WebEwoosoft Co., Ltd. · 2021
- This deviceK230468 EzDent WebEwoosoft Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK250716 Image OneInfomed Software, S.L. · 2025
Show all 13 generations
- Root · 13 generations backK930527 Dental LinkEscan, Inc. · 1993
- 12 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 11 generations backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- 10 generations backK050744 Kavo Ergocom/ErgocamKavo America Corporation · 2005
- 9 generations backK060178 Vix Win ProGendex Dental Systems · 2006 · Recalled
- 8 generations backK131594 Ezdenti-I; E2; Prora ViewEwoosoft Co., Ltd. · 2013
- 7 generations backK150747 EzDent-i /E2/Prora ViewLK Consulting Group USA, Inc. · 2015
- 6 generations backK161117 EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2016
- 5 generations backK163533 EzDent-i; E2; ProraViewEwoosoft Co., Ltd. · 2017
- 4 generations backK172364 EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2017
- 3 generations backK190087 EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2019
- 2 generations backK202116 EzDent-i/ E2/ Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2020
- 1 generation backK211700 EzDent WebEwoosoft Co., Ltd. · 2021
- This deviceK230468 EzDent WebEwoosoft Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K250716Image OneInfomed Software, S.L. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −12 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −11 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| −10 | K050744 | Kavo Ergocom/Ergocam | Kavo America Corporation | 2005 | — |
| −9 | K060178 | Vix Win Pro | Gendex Dental Systems | 2006 | 1 |
| −8 | K131594 | Ezdenti-I; E2; Prora View | Ewoosoft Co., Ltd. | 2013 | — |
| −7 | K150747 | EzDent-i /E2/Prora View | LK Consulting Group USA, Inc. | 2015 | — |
| −6 | K161117 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2016 | — |
| −5 | K163533 | EzDent-i; E2; ProraView | Ewoosoft Co., Ltd. | 2017 | — |
| −4 | K172364 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2017 | — |
| −3 | K190087 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2019 | — |
| −2 | K202116 | EzDent-i/ E2/ Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2020 | — |
| −1 | K211700 | EzDent Web | Ewoosoft Co., Ltd. | 2021 | — |
| 0 (this device) | K230468 | EzDent Web | Ewoosoft Co., Ltd. | 2023 | — |
| +1 | K250716 | Image One | Infomed Software, S.L. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K211700 | EzDent WebSummary page 4…5. Predicate Device: • Manufacturer: Ewoosoft Co., Ltd. • Trade/Device name: EzDent Web • Version #: v1.0 • 510(k) number: K211700 • Regulation number 21 CFR 892.2050 • Regulation name: Picture Archiving and Communications System… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250716 | Image One | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K250716 (Infomed Software, S.L., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
EzDent Web is a dental imaging software that is intended to provide viewer and image processing tools for maxillofacial radiographic images. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.
EzDent Web is intended for use as software to acquire, view, and save 2D and 3D image files, to load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment, and to provide 3D visualization and 2D analysis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K230468 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230468: EzDent Web.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230468
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026