510(k) · Cleared
ClearedDenti.AI Detect
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Denti.Ai Technology, Inc. · MYN Analyzer, Medical Image
Cleared on Oct 6, 2023 as substantially equivalent to K210365 (Pearl, Inc., 2022) and 1 other predicate after a 261-day review. Its family tree reaches back 9 generations to 1993. 1 later device descends from it.
- Decided
- Oct 6, 2023
- Review
- 261 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K930527 (1993). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK930527 Dental LinkEscan, Inc. · 1993
- 5 generations between
- 3 generations backK173094 OrthoVisionEwoosoft Co., Ltd. · 2017
- 2 generations backK192888 EzOrthoEwoosoft Co., Ltd. · 2020
- 1 generation backK210187 Overjet Dental AssistOverjet, Inc. · 2021
- This deviceK230144 Denti.AI DetectDenti.Ai Technology, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK250525 Second Opinion® PanoramicPearl, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK930527 Dental LinkEscan, Inc. · 1993
- 8 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 7 generations backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- 6 generations backK043104 Kodak Orthodontic Imaging and Oms Imaging 8.0Practiceworks, Inc. · 2005
- 5 generations backK122427 CS Orthodontic Imaging Software CS Oms Imaging SoftwareCarestream Dental, LLC · 2012
- 4 generations backK131570 OrthovisionEwoosoft Co., Ltd. · 2013
- 3 generations backK173094 OrthoVisionEwoosoft Co., Ltd. · 2017
- 2 generations backK192888 EzOrthoEwoosoft Co., Ltd. · 2020
- 1 generation backK210187 Overjet Dental AssistOverjet, Inc. · 2021
- This deviceK230144 Denti.AI DetectDenti.Ai Technology, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K250525Second Opinion® PanoramicPearl, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −8 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −7 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| −6 | K043104 | Kodak Orthodontic Imaging and Oms Imaging 8.0 | Practiceworks, Inc. | 2005 | — |
| −5 | K122427 | CS Orthodontic Imaging Software CS Oms Imaging Software | Carestream Dental, LLC | 2012 | — |
| −4 | K131570 | Orthovision | Ewoosoft Co., Ltd. | 2013 | — |
| −3 | K173094 | OrthoVision | Ewoosoft Co., Ltd. | 2017 | — |
| −2 | K192888 | EzOrtho | Ewoosoft Co., Ltd. | 2020 | — |
| −1 | K210187 | Overjet Dental Assist | Overjet, Inc. | 2021 | — |
| 0 (this device) | K230144 | Denti.AI Detect | Denti.Ai Technology, Inc. | 2023 | — |
| +1 | K250525 | Second Opinion® Panoramic | Pearl, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (2)
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 |
|---|---|---|---|
| * | K210365 | Second OpinionSummary page 4…d Communication System Regulatory Class: II Product Code: LLZ 3. PREDICATE DEVICE Primary Predicate: Pearl Second Opinion (K210365) Secondary Predicate: Overjet Dental Assist (K210187) 510(k) Summary - K230144… | 2022 |
| * | K210187 | Overjet Dental AssistSummary page 4…roduct Code: LLZ 3. PREDICATE DEVICE Primary Predicate: Pearl Second Opinion (K210365) Secondary Predicate: Overjet Dental Assist (K210187) 510(k) Summary - K230144 Page 2 of 6 4.… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250525 | Second Opinion® Panoramic | 2025 | 0 |
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 30 years and passes through 8 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K250525 (Pearl, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K210365.
How does its category compare?
All MYN devicesMYN Analyzer, Medical Image: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Denti.AI Detect is a Computer-Assisted Detection (CADe) software device intended to be used by dental professionals, comprising dentists and dental specialists, while reading extraoral and intraoral 2D dental radiographs. The device aims to assist in detecting and highlighting uncategorized regions of interest (ROIs) within the teeth area, which include caries and periapical radiolucency, as a second reader. The device is also intended to aid in the…
Read the full statement (124 words)
Denti.AI Detect is a Computer-Assisted Detection (CADe) software device intended to be used by dental professionals, comprising dentists and dental specialists, while reading extraoral and intraoral 2D dental radiographs.
The device aims to assist in detecting and highlighting uncategorized regions of interest (ROIs) within the teeth area, which include caries and periapical radiolucency, as a second reader. The device is also intended to aid in the measurements of mesial and distal bone levels associated with each tooth.
The device is aimed to be used with images from the patients of 22 years age and older without remaining primary dentition. The device is not intended to replace 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/K230144 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230144: Denti.AI Detect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230144
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