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 Oct 4, 2021 as substantially equivalent to K202116 (Ewoosoft Co., Ltd., 2020) after a 116-day review. Its family tree reaches back 12 generations to 1993. 4 later devices descend from it.
- Decided
- Oct 4, 2021
- Review
- 116 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K930527 (1993). 4 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK930527 Dental LinkEscan, Inc. · 1993
- 8 generations between
- 3 generations backK172364 EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2017
- 2 generations backK190087 EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2019
- 1 generation backK202116 EzDent-i/ E2/ Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2020
- This deviceK211795 EzDent-i/ E2/ Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2021
- Descendant · cites it directly · 3 of its ownK222145 EzDent-i / E2 / Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2022
- Descendant · 2 generations on · 2 of its ownK223820 EzDent-i / E2 / Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2023
- Descendant · 3 generations on · 1 of its ownK241114 EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)Ewoosoft Co., Ltd. · 2024
- Descendant · 4 generations on · 0 of its ownK250005 Clever OneEwoosoft Co., Ltd. · 2025
Show all 12 generations
- Root · 12 generations backK930527 Dental LinkEscan, Inc. · 1993
- 11 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 10 generations backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- 9 generations backK050744 Kavo Ergocom/ErgocamKavo America Corporation · 2005
- 8 generations backK060178 Vix Win ProGendex Dental Systems · 2006 · Recalled
- 7 generations backK131594 Ezdenti-I; E2; Prora ViewEwoosoft Co., Ltd. · 2013
- 6 generations backK150747 EzDent-i /E2/Prora ViewLK Consulting Group USA, Inc. · 2015
- 5 generations backK161117 EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2016
- 4 generations backK163533 EzDent-i; E2; ProraViewEwoosoft Co., Ltd. · 2017
- 3 generations backK172364 EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2017
- 2 generations backK190087 EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2019
- 1 generation backK202116 EzDent-i/ E2/ Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2020
- This deviceK211795 EzDent-i/ E2/ Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2021
Most influential descendants
Showing 4 of 4 · See all- K222145EzDent-i / E2 / Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2022 · cites it directly3descendants
- K223820EzDent-i / E2 / Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2023 · 2 generations on2descendants
- K241114EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)Ewoosoft Co., Ltd. · 2024 · 3 generations on1descendant
- K250005Clever OneEwoosoft Co., Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −11 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −10 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| −9 | K050744 | Kavo Ergocom/Ergocam | Kavo America Corporation | 2005 | — |
| −8 | K060178 | Vix Win Pro | Gendex Dental Systems | 2006 | 1 |
| −7 | K131594 | Ezdenti-I; E2; Prora View | Ewoosoft Co., Ltd. | 2013 | — |
| −6 | K150747 | EzDent-i /E2/Prora View | LK Consulting Group USA, Inc. | 2015 | — |
| −5 | K161117 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2016 | — |
| −4 | K163533 | EzDent-i; E2; ProraView | Ewoosoft Co., Ltd. | 2017 | — |
| −3 | K172364 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2017 | — |
| −2 | K190087 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2019 | — |
| −1 | K202116 | EzDent-i/ E2/ Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2020 | — |
| 0 (this device) | K211795 | EzDent-i/ E2/ Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2021 | — |
| +1 | K222145 | EzDent-i / E2 / Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2022 | — |
| +2 | K223820 | EzDent-i / E2 / Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2023 | — |
| +3 | K241114 | EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) | Ewoosoft Co., Ltd. | 2024 | — |
| +4 | K250005 | Clever One | Ewoosoft Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 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 21.6 · 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 |
|---|---|---|---|
| * | K202116 | EzDent-i/ E2/ Prora View/ Smart M ViewerSummary page 4…atory Class: Class II • Product Code: LLZ 5. Predicate Device: • Manufacturer: Ewoosoft Co., Ltd. • Trade/Device Name: EzDent-i v3.1 • 510k Number: K202116 • Regulation Number: 21 CFR 892.2050 • Regulation Name: Medical Image Management and Processing System • Regulator… | 2020 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222145 | EzDent-i / E2 / Prora View/ Smart M Viewer | 2022 | 3 |
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 28 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K222145 (Ewoosoft Co., Ltd., 2022) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K202116.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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/K211795 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211795: 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 3, 2026. https://510kreport.com/device/K211795
Report an extraction error
Are you the manufacturer?
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