510(k) · Cleared
ClearedOverjet Multi-Image Caries and Charting Assist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Overjet, Inc. · MYN Analyzer, Medical Image
Cleared on Aug 6, 2026 as substantially equivalent to K222746 (Overjet, Inc., 2023) and 2 other predicates after a 128-day review. Its family tree reaches back 14 generations to 1993.
- Decided
- Aug 6, 2026
- Review
- 128 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K930527 (1993). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK930527 Dental LinkEscan, Inc. · 1993
- 10 generations between
- 3 generations backK222054 Denti.AI Auto-ChartDenti.Ai Technology, Inc. · 2022
- 2 generations backK233590 Overjet Charting AssistOverjet, Inc. · 2024
- 1 generation backK241684 Overjet Charting AssistOverjet, Inc. · 2024
- This deviceK261059 Overjet Multi-Image Caries and Charting AssistOverjet, Inc. · 2026
Show all 14 generations
- Root · 14 generations backK930527 Dental LinkEscan, Inc. · 1993
- 13 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 12 generations backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- 11 generations backK043104 Kodak Orthodontic Imaging and Oms Imaging 8.0Practiceworks, Inc. · 2005
- 10 generations backK122427 CS Orthodontic Imaging Software CS Oms Imaging SoftwareCarestream Dental, LLC · 2012
- 9 generations backK131570 OrthovisionEwoosoft Co., Ltd. · 2013
- 8 generations backK173094 OrthoVisionEwoosoft Co., Ltd. · 2017
- 7 generations backK192888 EzOrthoEwoosoft Co., Ltd. · 2020
- 6 generations backK202948 EzOrthoEwoosoft Co., Ltd. · 2020
- 5 generations backK211793 EzOrthoEwoosoft Co., Ltd. · 2021
- 4 generations backK220003 EzOrtho v1.3Ewoosoft Co., Ltd. · 2022
- 3 generations backK222054 Denti.AI Auto-ChartDenti.Ai Technology, Inc. · 2022
- 2 generations backK233590 Overjet Charting AssistOverjet, Inc. · 2024
- 1 generation backK241684 Overjet Charting AssistOverjet, Inc. · 2024
- This deviceK261059 Overjet Multi-Image Caries and Charting AssistOverjet, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −13 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −12 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| −11 | K043104 | Kodak Orthodontic Imaging and Oms Imaging 8.0 | Practiceworks, Inc. | 2005 | — |
| −10 | K122427 | CS Orthodontic Imaging Software CS Oms Imaging Software | Carestream Dental, LLC | 2012 | — |
| −9 | K131570 | Orthovision | Ewoosoft Co., Ltd. | 2013 | — |
| −8 | K173094 | OrthoVision | Ewoosoft Co., Ltd. | 2017 | — |
| −7 | K192888 | EzOrtho | Ewoosoft Co., Ltd. | 2020 | — |
| −6 | K202948 | EzOrtho | Ewoosoft Co., Ltd. | 2020 | — |
| −5 | K211793 | EzOrtho | Ewoosoft Co., Ltd. | 2021 | — |
| −4 | K220003 | EzOrtho v1.3 | Ewoosoft Co., Ltd. | 2022 | — |
| −3 | K222054 | Denti.AI Auto-Chart | Denti.Ai Technology, Inc. | 2022 | — |
| −2 | K233590 | Overjet Charting Assist | Overjet, Inc. | 2024 | — |
| −1 | K241684 | Overjet Charting Assist | Overjet, Inc. | 2024 | — |
| 0 (this device) | 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 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 MYN? 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 MYN device
- #1 K210365 Second Opinionscore 30.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K222746 | Overjet Caries AssistSummary page 6…f age and older. 8. Predicate Device(s) A.Device: Overjet CariesAssist Manufacturer: Overjet, Inc. 510(k): K222746 Product code: MYN Common Name: Analyzer, Medical Image Regulation: 21 CFR 892.… | 2023 |
| * | K241684 | Overjet Charting AssistSummary page 6…on Name: Medical image Analyzer B. Device: Overjet Charting Assist Manufacturer: Overjet, Inc. 510(k): K241684 Product Code: QIH Common Name: Automated Radiological Image Processing System R… | 2024 |
| * | K233738 | Overjet Caries Assist-PediatricSummary page 6…and Processing System C. Device: Overjet Caries Assist - Pediatric Manufacturer: Overjet, Inc. 510(k): K233738 Product Code: MYN Common Name: Analyzer, Medical Image Regulation: 21… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 19 ancestors has a recall of any class.
- 6 other devices also cite its predicate K222746.
How does its category compare?
All MYN devicesMYN Analyzer, Medical Image: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MYN
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MYN
210in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MYN
No recall names MYN since 2007.
Adverse event reports per year · MYN
2in 2025
MAUDE reports naming product code MYN, 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 | 5 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 6 | — | 0 | 0 |
| 2013 | 4 | — | 0 | 0 |
| 2014 | 3 | — | 0 | 0 |
| 2015 | 3 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 3 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 5 | 273 | 0 | 0 |
| 2023 | 10 | 229 | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 14 | 210 | 0 | 2 |
| 2026 | 7 | 128 | 0 | — |
What is it indicated for?
Overjet Multi-Image Caries and Charting Assist is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries (primary enamel, primary dentin and secondary) and in the detection of tooth anatomy (enamel, pulp), tooth numbering and dental structures added through past restorative treatments: implants, crowns, endodontic treatment, fillings. The device uses AI/ML…
Read the full statement (163 words)
Overjet Multi-Image Caries and Charting Assist is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries (primary enamel, primary dentin and secondary) and in the detection of tooth anatomy (enamel, pulp), tooth numbering and dental structures added through past restorative treatments: implants, crowns, endodontic treatment, fillings.
The device uses AI/ML algorithms to analyze all available dental radiographs of the patient jointly, evaluating findings at the patient-tooth level, to support the clinician's review. The device is not intended as a replacement for a complete dentist’s review or their clinical judgment. The device is intended to detect caries on bitewing (BW) and periapical (PA) radiographs in patients 4 years of age and older, with visual differentiation between incipient caries, non-incipient caries and secondary caries. The device is intended to detect tooth anatomy, tooth numbering, and past restorative treatments on bitewing (BW) and periapical (PA) and panoramic (Pano) radiographs in patients 4 years of age and older.
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/K261059 · printed Nov 4, 2026
Cite this page
510(k) Report. “K261059: Overjet Multi-Image Caries and Charting Assist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K261059
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026