510(k) · Cleared
ClearedBetter Diagnostics Caries Assist (BDCA) Version 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Better Diagnostics AI Corp. · MYN Analyzer, Medical Image
Cleared on Mar 11, 2025 as substantially equivalent to K222746 (Overjet, Inc., 2023) after a 270-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Mar 11, 2025
- Review
- 270 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P980025 (1998). No later device cites it as a predicate yet.
- 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 deviceK241725 Better Diagnostics Caries Assist (BDCA) Version 1.0Better Diagnostics AI Corp. · 2025
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) | K241725 | Better Diagnostics Caries Assist (BDCA) Version 1.0 | Better Diagnostics AI Corp. | 2025 | — |
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 6…USA 3. Predicate Device Proprietary Name of Device: Overjet Caries Assist Software (Version 1.0) Premarket Notification: K222746 Common or Usual Name: Medical image analyzer Classification Panel: Radiology Regulation Number: 21 CFR § 892.2070… | 2023 |
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 27 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 3 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. 2025, 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?
Better Diagnostics Caries Assist is a radiological, automated, concurrent read, CADe software
intended to identify and localize carious lesions on bitewings and periapical radiographs acquired
from patients aged 18 years or older. Better Diagnostics Caries assist is indicated for use by board
licensed dentists. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241725: Better Diagnostics Caries Assist (BDCA) Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241725
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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