510(k) · Cleared
ClearedOverjet Caries Assist-Pediatric
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 Mar 4, 2024 as substantially equivalent to K222746 (Overjet, Inc., 2023) after a 103-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.
- Decided
- Mar 4, 2024
- Review
- 103 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P980025 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backP980025 Logicon Caries DetectorCarestream Dental, LLC · 1998 · Recalled
- 2 generations backK212519 Overjet Caries AssistOverjet, Inc. · 2022
- 1 generation backK222746 Overjet Caries AssistOverjet, Inc. · 2023
- This deviceK233738 Overjet Caries Assist-PediatricOverjet, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK261059 Overjet Multi-Image Caries and Charting AssistOverjet, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K261059Overjet Multi-Image Caries and Charting AssistOverjet, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P980025 | Logicon Caries Detector | Carestream Dental, LLC | 1998 | 1 |
| −2 | K212519 | Overjet Caries Assist | Overjet, Inc. | 2022 | — |
| −1 | K222746 | Overjet Caries Assist | Overjet, Inc. | 2023 | — |
| 0 (this device) | K233738 | Overjet Caries Assist-Pediatric | Overjet, Inc. | 2024 | — |
| +1 | K261059 | Overjet Multi-Image Caries and Charting Assist | Overjet, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 29.9 · 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? (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 |
|---|---|---|---|
| * | K222746 | Overjet Caries AssistSummary page 4…er, Medical Image Regulation Number: 892.2070 Product Code: MYN Legally Marketed Predicate Device: Overjet Caries Assist Predicate Product Code: MYN Predicate K number: K222746 Device Description Summary Overjet Caries Assist-Pediatric (OCA-Ped) is a radiological, automated, concurrent-read, computer-as… | 2023 |
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 |
|---|---|---|---|
| K261059 | Overjet Multi-Image Caries and Charting Assist | 2026 | 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 26 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K261059 (Overjet, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 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. 2024, 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 Caries Assist-Pediatric (OCA-Ped) is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the clinician to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist’s review or their…
Read the full statement (113 words)
Overjet Caries Assist-Pediatric (OCA-Ped) is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the clinician to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist’s review or their clinical judgment that takes into account other relevant information from the image, patient history, or actual in vivo clinical assessment.
The intended patient population of the device is patients aged 4-11 years old that have primary or permanent teeth (primary or mixed dentition) and are indicated for dental radiographs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233738 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233738: Overjet Caries Assist-Pediatric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233738
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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