510(k) · Cleared
ClearedOverjet Charting Assist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Overjet, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Feb 23, 2024 as substantially equivalent to K222054 (Denti.Ai Technology, Inc., 2022) after a 107-day review. Its family tree reaches back 12 generations to 1993. 2 later devices descend from it.
- Decided
- Feb 23, 2024
- Review
- 107 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K930527 (1993). 13 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK930527 Dental LinkEscan, Inc. · 1993
- 8 generations between
- 3 generations backK211793 EzOrthoEwoosoft Co., Ltd. · 2021
- 2 generations backK220003 EzOrtho v1.3Ewoosoft Co., Ltd. · 2022
- 1 generation backK222054 Denti.AI Auto-ChartDenti.Ai Technology, Inc. · 2022
- This deviceK233590 Overjet Charting AssistOverjet, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK241684 Overjet Charting AssistOverjet, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK261059 Overjet Multi-Image Caries and Charting AssistOverjet, Inc. · 2026
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 backK043104 Kodak Orthodontic Imaging and Oms Imaging 8.0Practiceworks, Inc. · 2005
- 8 generations backK122427 CS Orthodontic Imaging Software CS Oms Imaging SoftwareCarestream Dental, LLC · 2012
- 7 generations backK131570 OrthovisionEwoosoft Co., Ltd. · 2013
- 6 generations backK173094 OrthoVisionEwoosoft Co., Ltd. · 2017
- 5 generations backK192888 EzOrthoEwoosoft Co., Ltd. · 2020
- 4 generations backK202948 EzOrthoEwoosoft Co., Ltd. · 2020
- 3 generations backK211793 EzOrthoEwoosoft Co., Ltd. · 2021
- 2 generations backK220003 EzOrtho v1.3Ewoosoft Co., Ltd. · 2022
- 1 generation backK222054 Denti.AI Auto-ChartDenti.Ai Technology, Inc. · 2022
- This deviceK233590 Overjet Charting AssistOverjet, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView 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 | K043104 | Kodak Orthodontic Imaging and Oms Imaging 8.0 | Practiceworks, Inc. | 2005 | — |
| −8 | K122427 | CS Orthodontic Imaging Software CS Oms Imaging Software | Carestream Dental, LLC | 2012 | — |
| −7 | K131570 | Orthovision | Ewoosoft Co., Ltd. | 2013 | — |
| −6 | K173094 | OrthoVision | Ewoosoft Co., Ltd. | 2017 | — |
| −5 | K192888 | EzOrtho | Ewoosoft Co., Ltd. | 2020 | — |
| −4 | K202948 | EzOrtho | Ewoosoft Co., Ltd. | 2020 | — |
| −3 | K211793 | EzOrtho | Ewoosoft Co., Ltd. | 2021 | — |
| −2 | K220003 | EzOrtho v1.3 | Ewoosoft Co., Ltd. | 2022 | — |
| −1 | K222054 | Denti.AI Auto-Chart | Denti.Ai Technology, Inc. | 2022 | — |
| 0 (this device) | K233590 | Overjet Charting Assist | Overjet, Inc. | 2024 | — |
| +1 | K241684 | Overjet Charting Assist | Overjet, Inc. | 2024 | — |
| +2 | 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 | 1 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 7 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 |
|---|---|---|---|
| * | K222054 | Denti.AI Auto-ChartSummary page 4…d processing system Regulation Number: 892.2050 Product Code: QIH Legally Marketed Predicate Device: Denti.AI Auto-Chart Predicate Product Code: LLZ Predicate K number: K222054 Device Description Summary Overjet Charting Assist is a Medical Image Management and Processing System (MIMPS) device aimed to… | 2022 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241684 | Overjet Charting Assist | 2024 | 1 |
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 31 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K241684 (Overjet, Inc., 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
Overjet Charting Assist is a Medical Image Management and Processing System (MIMPS) intended to detect natural dental structures including detection of tooth anatomy (enamel, pulp), and tooth numbering, as well as dental structures added through past restorative treatments: implants, crowns, endodontic treatment (previous root canal treatment), fillings. The device is intended to assist dental professionals in producing dental charts based on image…
Read the full statement (125 words)
Overjet Charting Assist is a Medical Image Management and Processing System (MIMPS) intended to detect natural dental structures including detection of tooth anatomy (enamel, pulp), and tooth numbering, as well as dental structures added through past restorative treatments: implants, crowns, endodontic treatment (previous root canal treatment), fillings. The device is intended to assist dental professionals in producing dental charts based on image analysis.
The Overjet Charting Assist detects these findings on bitewing (BW) and periapical (PA) images for patients with primary and/or permanent teeth (Ages 5 and above), and panoramic (Pano) radiographs for patients with only permanent 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/K233590 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233590: Overjet Charting Assist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233590
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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