510(k) · Cleared
ClearedEzOrtho v1.3
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 Feb 23, 2022 as substantially equivalent to K211793 (Ewoosoft Co., Ltd., 2021) after a 50-day review. Its family tree reaches back 10 generations to 1993. 4 later devices descend from it.
- Decided
- Feb 23, 2022
- Review
- 50 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K930527 (1993). 11 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK930527 Dental LinkEscan, Inc. · 1993
- 6 generations between
- 3 generations backK192888 EzOrthoEwoosoft Co., Ltd. · 2020
- 2 generations backK202948 EzOrthoEwoosoft Co., Ltd. · 2020
- 1 generation backK211793 EzOrthoEwoosoft Co., Ltd. · 2021
- This deviceK220003 EzOrtho v1.3Ewoosoft Co., Ltd. · 2022
- Descendant · cites it directly · 3 of its ownK222054 Denti.AI Auto-ChartDenti.Ai Technology, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK233590 Overjet Charting AssistOverjet, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK241684 Overjet Charting AssistOverjet, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK261059 Overjet Multi-Image Caries and Charting AssistOverjet, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK930527 Dental LinkEscan, Inc. · 1993
- 9 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 8 generations backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- 7 generations backK043104 Kodak Orthodontic Imaging and Oms Imaging 8.0Practiceworks, Inc. · 2005
- 6 generations backK122427 CS Orthodontic Imaging Software CS Oms Imaging SoftwareCarestream Dental, LLC · 2012
- 5 generations backK131570 OrthovisionEwoosoft Co., Ltd. · 2013
- 4 generations backK173094 OrthoVisionEwoosoft Co., Ltd. · 2017
- 3 generations backK192888 EzOrthoEwoosoft Co., Ltd. · 2020
- 2 generations backK202948 EzOrthoEwoosoft Co., Ltd. · 2020
- 1 generation backK211793 EzOrthoEwoosoft Co., Ltd. · 2021
- This deviceK220003 EzOrtho v1.3Ewoosoft Co., Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K222054Denti.AI Auto-ChartDenti.Ai Technology, Inc. · 2022 · cites it directly3descendants
- K233590Overjet Charting AssistOverjet, Inc. · 2024 · 2 generations on2descendants
- K241684Overjet Charting AssistOverjet, Inc. · 2024 · 3 generations on1descendant
- K261059Overjet Multi-Image Caries and Charting AssistOverjet, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −9 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −8 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| −7 | K043104 | Kodak Orthodontic Imaging and Oms Imaging 8.0 | Practiceworks, Inc. | 2005 | — |
| −6 | K122427 | CS Orthodontic Imaging Software CS Oms Imaging Software | Carestream Dental, LLC | 2012 | — |
| −5 | K131570 | Orthovision | Ewoosoft Co., Ltd. | 2013 | — |
| −4 | K173094 | OrthoVision | Ewoosoft Co., Ltd. | 2017 | — |
| −3 | K192888 | EzOrtho | Ewoosoft Co., Ltd. | 2020 | — |
| −2 | K202948 | EzOrtho | Ewoosoft Co., Ltd. | 2020 | — |
| −1 | K211793 | EzOrtho | Ewoosoft Co., Ltd. | 2021 | — |
| 0 (this device) | K220003 | EzOrtho v1.3 | Ewoosoft Co., Ltd. | 2022 | — |
| +1 | K222054 | Denti.AI Auto-Chart | Denti.Ai Technology, Inc. | 2022 | — |
| +2 | K233590 | Overjet Charting Assist | Overjet, Inc. | 2024 | — |
| +3 | K241684 | Overjet Charting Assist | Overjet, Inc. | 2024 | — |
| +4 | K261059 | Overjet Multi-Image Caries and Charting Assist | Overjet, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K211793 | EzOrthoSummary page 5…2 • Classification:Medical Image Management and Processing System (21CFR 892.2050, Product code LLZ, Class 2, Radiology) • 510(k) Number: K211793 Page 2 of 4 10. Substantial Equivalence:… | 2021 |
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 |
|---|---|---|---|
| K222054 | Denti.AI Auto-Chart | 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 29 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K222054 (Denti.Ai Technology, Inc., 2022) has gone furthest, with 3 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. 2022, 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?
EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists.
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/K220003 · printed Nov 5, 2026
Cite this page
510(k) Report. “K220003: EzOrtho v1.3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K220003
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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