510(k) · Cleared
ClearedOverjet Caries 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 May 10, 2022 as substantially equivalent to P980025 (Carestream Dental, LLC, 1998) after a 273-day review. Its family tree reaches back 1 generation to 1998. 12 later devices descend from it.
- Decided
- May 10, 2022
- Review
- 273 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P980025 (1998). 12 later devices descend from it, 2 citing it directly.
- Root · 1 generation backP980025 Logicon Caries DetectorCarestream Dental, LLC · 1998 · Recalled
- This deviceK212519 Overjet Caries AssistOverjet, Inc. · 2022
- Descendant · cites it directly · 9 of its ownK222746 Overjet Caries AssistOverjet, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK240003 Velmeni for Dentists (V4D)Velmeni, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK242437 Smile Dx®Cube Click, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK233738 Overjet Caries Assist-PediatricOverjet, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK261059 Overjet Multi-Image Caries and Charting AssistOverjet, Inc. · 2026
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K222746Overjet Caries AssistOverjet, Inc. · 2023 · cites it directly9descendants
- K240003Velmeni for Dentists (V4D)Velmeni, Inc. · 2024 · 2 generations on2descendants
- K242437Smile Dx®Cube Click, Inc. · 2025 · cites it directly1descendant
- K233738Overjet Caries Assist-PediatricOverjet, Inc. · 2024 · 2 generations on1descendant
- K261059Overjet Multi-Image Caries and Charting AssistOverjet, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P980025 | Logicon Caries Detector | Carestream Dental, LLC | 1998 | 1 |
| 0 (this device) | K212519 | Overjet Caries Assist | Overjet, Inc. | 2022 | — |
| +1 | K222746 | Overjet Caries Assist | Overjet, Inc. | 2023 | — |
| +2 | K240003 | Velmeni for Dentists (V4D) | Velmeni, Inc. | 2024 | — |
| +1 | K242437 | Smile Dx® | Cube Click, Inc. | 2025 | — |
| +2 | K233738 | Overjet Caries Assist-Pediatric | Overjet, Inc. | 2024 | — |
| +2 | K261059 | Overjet Multi-Image Caries and Charting Assist | Overjet, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 7 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | P980025 | Logicon Caries DetectorSummary page 6…tation when deemed necessary. 10. Predicate Device Device - Logicon Caries Detector Manufacturer - Carestream Dental PMA - P980025 (down-classified to Class II under 85 FR 3548, Jan. 22, 2020) Overjet Inc. Overjet Caries Assist Software: K21251… | 1998 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All MYN devicesMYN Analyzer, Medical Image: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
The Overjet Caries Assist (OCA) is a radiological, automated, concurrent read, computer-assisted detection software intended to aid in the detection and segmentation of caries on bitewing radiographs. The device provides additional information for the dentist 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, and actual in vivo clinical assessment.
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/K212519 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212519: Overjet Caries Assist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212519
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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