510(k) · Cleared
ClearedEzDent-i/ E2/ Prora View/ Smart M Viewer
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 Aug 21, 2020 as substantially equivalent to K190087 (Ewoosoft Co., Ltd., 2019) after a 22-day review. Its family tree reaches back 11 generations to 1993. 8 later devices descend from it.
- Decided
- Aug 21, 2020
- Review
- 22 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K930527 (1993). 8 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK930527 Dental LinkEscan, Inc. · 1993
- 7 generations between
- 3 generations backK163533 EzDent-i; E2; ProraViewEwoosoft Co., Ltd. · 2017
- 2 generations backK172364 EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2017
- 1 generation backK190087 EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2019
- This deviceK202116 EzDent-i/ E2/ Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2020
- Descendant · cites it directly · 4 of its ownK211795 EzDent-i/ E2/ Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2021
- Descendant · 2 generations on · 3 of its ownK222145 EzDent-i / E2 / Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2022
- Descendant · 3 generations on · 2 of its ownK223820 EzDent-i / E2 / Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2023
- Descendant · cites it directly · 2 of its ownK211700 EzDent WebEwoosoft Co., Ltd. · 2021
- Descendant · 4 generations on · 1 of its ownK241114 EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)Ewoosoft Co., Ltd. · 2024
Show all 11 generations
- Root · 11 generations backK930527 Dental LinkEscan, Inc. · 1993
- 10 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 9 generations backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- 8 generations backK050744 Kavo Ergocom/ErgocamKavo America Corporation · 2005
- 7 generations backK060178 Vix Win ProGendex Dental Systems · 2006 · Recalled
- 6 generations backK131594 Ezdenti-I; E2; Prora ViewEwoosoft Co., Ltd. · 2013
- 5 generations backK150747 EzDent-i /E2/Prora ViewLK Consulting Group USA, Inc. · 2015
- 4 generations backK161117 EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2016
- 3 generations backK163533 EzDent-i; E2; ProraViewEwoosoft Co., Ltd. · 2017
- 2 generations backK172364 EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2017
- 1 generation backK190087 EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2019
- This deviceK202116 EzDent-i/ E2/ Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K211795EzDent-i/ E2/ Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2021 · cites it directly4descendants
- K222145EzDent-i / E2 / Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2022 · 2 generations on3descendants
- K223820EzDent-i / E2 / Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2023 · 3 generations on2descendants
- K211700EzDent WebEwoosoft Co., Ltd. · 2021 · cites it directly2descendants
- K241114EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)Ewoosoft Co., Ltd. · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −10 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −9 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| −8 | K050744 | Kavo Ergocom/Ergocam | Kavo America Corporation | 2005 | — |
| −7 | K060178 | Vix Win Pro | Gendex Dental Systems | 2006 | 1 |
| −6 | K131594 | Ezdenti-I; E2; Prora View | Ewoosoft Co., Ltd. | 2013 | — |
| −5 | K150747 | EzDent-i /E2/Prora View | LK Consulting Group USA, Inc. | 2015 | — |
| −4 | K161117 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2016 | — |
| −3 | K163533 | EzDent-i; E2; ProraView | Ewoosoft Co., Ltd. | 2017 | — |
| −2 | K172364 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2017 | — |
| −1 | K190087 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2019 | — |
| 0 (this device) | K202116 | EzDent-i/ E2/ Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2020 | — |
| +1 | K211795 | EzDent-i/ E2/ Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2021 | — |
| +2 | K222145 | EzDent-i / E2 / Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2022 | — |
| +3 | K223820 | EzDent-i / E2 / Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2023 | — |
| +1 | K211700 | EzDent Web | Ewoosoft Co., Ltd. | 2021 | — |
| +4 | K241114 | EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) | Ewoosoft Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K190087 | EzDent-i / E2 / Prora ViewSummary page 5…c, and intra-oral imaging equipment. 9. Predicate Device: • Manufacturer: Ewoosoft Co., Ltd. • Device: EzDent-i / E2 / ProraView • 510(k) Number: K190087 10. Substantial Equivalence: EzDent-i v3.1 described in this 510(k) has the same intended use and the same technical char… | 2019 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 27 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K211795 (Ewoosoft Co., Ltd., 2021) has gone furthest, with 4 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. 2020, 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-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. 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-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.
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/K202116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202116: EzDent-i/ E2/ Prora View/ Smart M Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202116
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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