510(k) · Cleared
ClearedVelmeni for Dentists (V4D)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Velmeni, Inc. · MYN Analyzer, Medical Image
Cleared on Aug 30, 2024 as substantially equivalent to K222746 (Overjet, Inc., 2023) after a 241-day review. Its family tree reaches back 3 generations to 1998. 2 later devices descend from it.
- Decided
- Aug 30, 2024
- Review
- 241 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P980025 (1998). 2 later devices descend from it, 2 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 deviceK240003 Velmeni for Dentists (V4D)Velmeni, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK252953 Velmeni for Dentists (V4D) Endo-PerioVelmeni, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK250753 VELMENI for DENTISTS (V4D)Velmeni, Inc. · 2025
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 |
|---|---|---|---|---|---|
| −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) | K240003 | Velmeni for Dentists (V4D) | Velmeni, Inc. | 2024 | — |
| +1 | K252953 | Velmeni for Dentists (V4D) Endo-Perio | Velmeni, Inc. | 2026 | — |
| +1 | K250753 | VELMENI for DENTISTS (V4D) | Velmeni, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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…21CFR892.2070 Product Code: MYN Device Class: Class II Predicate Device(s) Predicate Device(s): Overjet Caries Assist (K222746) Reference Device: Second Opinion (K210365) Reference Device: Denti.AI Detect (K230144) Intended Us… | 2023 |
| † | K210365 | Second Opinion | 2022 |
| † | K230144 | Denti.AI Detect | 2023 |
What descends from it? (2)
2 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?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K252953 (Velmeni, 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?
VELMENI for DENTISTS (V4D) is a concurrent-read, computer-assisted detection software intended to assist dentists in the clinical detection of dental caries, fillings/restorations, fixed prostheses, and implants in digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients 15 years of age or older. This device provides additional information for dentists in examining radiographs of patients’ teeth. This device is not intended…
Read the full statement (104 words)
VELMENI for DENTISTS (V4D) is a concurrent-read, computer-assisted detection software intended
to assist dentists in the clinical detection of dental caries, fillings/restorations, fixed prostheses, and
implants in digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients 15
years of age or older. This device provides additional information for dentists in examining
radiographs of patients’ teeth. This device is not intended as a replacement for a complete
examination by the dentist or their clinical judgment that considers other relevant information from
the image, patient history, or actual in vivo clinical assessment. Final diagnoses and patient
treatment plans are the responsibility of the dentist.
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/K240003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240003: Velmeni for Dentists (V4D).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240003
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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