510(k) · Cleared
ClearedSmile Dx®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cube Click, Inc. · MYN Analyzer, Medical Image
Cleared on May 14, 2025 as substantially equivalent to K212519 (Overjet, Inc., 2022) after a 271-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- May 14, 2025
- Review
- 271 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P980025 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backP980025 Logicon Caries DetectorCarestream Dental, LLC · 1998 · Recalled
- 1 generation backK212519 Overjet Caries AssistOverjet, Inc. · 2022
- This deviceK242437 Smile Dx®Cube Click, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK252086 DTX Studio AssistNobel Biocare C/O Medicim NV · 2025
Most influential descendants
Showing 1 of 1 · See all- K252086DTX Studio AssistNobel Biocare C/O Medicim NV · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P980025 | Logicon Caries Detector | Carestream Dental, LLC | 1998 | 1 |
| −1 | K212519 | Overjet Caries Assist | Overjet, Inc. | 2022 | — |
| 0 (this device) | K242437 | Smile Dx® | Cube Click, Inc. | 2025 | — |
| +1 | K252086 | DTX Studio Assist | Nobel Biocare C/O Medicim NV | 2025 | — |
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 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 |
|---|---|---|---|
| * | K212519 | Overjet Caries AssistSummary page 5…892.2070 Secondary Product Code LLZ 3. PRIMARY PREDICATE DEVICE INFORMATION Predicate Device Name Overjet Caries Assist Predicate Device K Number K212519 4. REFERENCE DEVICE(S) INFORMATION Predicate Device Name Second Opinion… | 2022 |
| † | K210365 | Second Opinion | 2022 |
| † | K210187 | Overjet Dental Assist | 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 |
|---|---|---|---|
| K252086 | DTX Studio Assist | 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 27 years and passes through 3 companies; a new generation was cleared every 23.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K252086 (Nobel Biocare C/O Medicim NV, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K212519.
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?
Smile Dx® is a computer-assisted detection (CADe) software designed to aid dentists in the review of digital files of bitewing and periapical radiographs of permanent teeth. It is intended to aid in the detection and segmentation of suspected dental findings which include: caries, periapical radiolucencies (PARL), restorations, and dental anatomy. Smile Dx® is also intended to aid dentists in the measurement (in millimeter and percentage measurements) of…
Read the full statement (119 words)
Smile Dx® is a computer-assisted detection (CADe) software designed to aid dentists in the review of digital files of bitewing and periapical radiographs of permanent teeth. It is intended to aid in the detection and segmentation of suspected dental findings which include: caries, periapical radiolucencies (PARL), restorations, and dental anatomy.
Smile Dx® is also intended to aid dentists in the measurement (in millimeter and percentage measurements) of mesial and distal bone levels associated with each tooth.
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.
Smile Dx® supports both digital and phosphor sensors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242437: Smile Dx®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242437
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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