510(k) · Cleared
ClearedDenti.AI Auto-Chart
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Denti.Ai Technology, Inc. · LLZ System, Image Processing, Radiological
Cleared on Nov 22, 2022 as substantially equivalent to K220003 (Ewoosoft Co., Ltd., 2022) after a 133-day review. Its family tree reaches back 11 generations to 1993. 3 later devices descend from it.
- Decided
- Nov 22, 2022
- Review
- 133 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K930527 (1993). 12 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK930527 Dental LinkEscan, Inc. · 1993
- 7 generations between
- 3 generations backK202948 EzOrthoEwoosoft Co., Ltd. · 2020
- 2 generations backK211793 EzOrthoEwoosoft Co., Ltd. · 2021
- 1 generation backK220003 EzOrtho v1.3Ewoosoft Co., Ltd. · 2022
- This deviceK222054 Denti.AI Auto-ChartDenti.Ai Technology, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK233590 Overjet Charting AssistOverjet, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK241684 Overjet Charting AssistOverjet, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK261059 Overjet Multi-Image Caries and Charting AssistOverjet, Inc. · 2026
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 backK043104 Kodak Orthodontic Imaging and Oms Imaging 8.0Practiceworks, Inc. · 2005
- 7 generations backK122427 CS Orthodontic Imaging Software CS Oms Imaging SoftwareCarestream Dental, LLC · 2012
- 6 generations backK131570 OrthovisionEwoosoft Co., Ltd. · 2013
- 5 generations backK173094 OrthoVisionEwoosoft Co., Ltd. · 2017
- 4 generations backK192888 EzOrthoEwoosoft Co., Ltd. · 2020
- 3 generations backK202948 EzOrthoEwoosoft Co., Ltd. · 2020
- 2 generations backK211793 EzOrthoEwoosoft Co., Ltd. · 2021
- 1 generation backK220003 EzOrtho v1.3Ewoosoft Co., Ltd. · 2022
- This deviceK222054 Denti.AI Auto-ChartDenti.Ai Technology, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See allView 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 | K043104 | Kodak Orthodontic Imaging and Oms Imaging 8.0 | Practiceworks, Inc. | 2005 | — |
| −7 | K122427 | CS Orthodontic Imaging Software CS Oms Imaging Software | Carestream Dental, LLC | 2012 | — |
| −6 | K131570 | Orthovision | Ewoosoft Co., Ltd. | 2013 | — |
| −5 | K173094 | OrthoVision | Ewoosoft Co., Ltd. | 2017 | — |
| −4 | K192888 | EzOrtho | Ewoosoft Co., Ltd. | 2020 | — |
| −3 | K202948 | EzOrtho | Ewoosoft Co., Ltd. | 2020 | — |
| −2 | K211793 | EzOrtho | Ewoosoft Co., Ltd. | 2021 | — |
| −1 | K220003 | EzOrtho v1.3 | Ewoosoft Co., Ltd. | 2022 | — |
| 0 (this device) | K222054 | Denti.AI Auto-Chart | Denti.Ai Technology, Inc. | 2022 | — |
| +1 | K233590 | Overjet Charting Assist | Overjet, Inc. | 2024 | — |
| +2 | K241684 | Overjet Charting Assist | Overjet, Inc. | 2024 | — |
| +3 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K220003 | EzOrtho v1.3Summary page 4…Processing System Regulatory Class: II Product Code: LLZ 3. PREDICATE DEVICE Predicate Device: Ewoosoft EzOrtho V1.3 (K220003) 4. DEVICE DESCRIPTION Denti.AI Auto-Chart is a Medical Image Management and Processing System (MIMPS) device aimed… | 2022 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233590 | Overjet Charting Assist | 2024 | 2 |
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 7 companies; a new generation was cleared every 2.4 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K233590 (Overjet, Inc., 2024) has gone furthest, with 2 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?
Denti.AI Auto-Chart is a Medical Image Management and Processing System (MIMPS) device aimed to assist dental professionals (Users), comprising general dentists, dental specialists, and dental hygienists, in detecting dental structures and producing dental charting data based on the interpretation of intraoral and extraoral 2D X-Ray images. Denti.AI Auto-Chart is intended to assist in: • Detecting natural dental structures: teeth and missing teeth •…
Read the full statement (153 words)
Denti.AI Auto-Chart is a Medical Image Management and Processing System (MIMPS) device aimed to assist dental professionals (Users), comprising general dentists, dental specialists, and dental hygienists, in detecting dental structures and producing dental charting data based on the interpretation of intraoral and extraoral 2D X-Ray images.
Denti.AI Auto-Chart is intended to assist in:
• Detecting natural dental structures: teeth and missing teeth
• Detecting dental structures added through past restorative treatment: implants, crowns, pontics, endodontic treatment, fillings
• Choosing treatment options
• Producing dental charts based on image analysis results as well as conditions added manually or produced by integrated CAD devices
The device is aimed to be used with images from the adult population only (≥22 years old and do not have remaining primary teeth). The device is not intended as a replacement for a complete clinician's review or clinical judgment that considers other relevant information from the image or patient history.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222054: Denti.AI Auto-Chart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222054
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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