510(k) · Cleared
ClearedSecond Opinion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pearl, Inc. · MYN Analyzer, Medical Image
Cleared on Mar 4, 2022 as substantially equivalent to P980025 (Carestream Dental, LLC, 1998) after a 389-day review. Its family tree reaches back 1 generation to 1998. 12 later devices descend from it.
- Decided
- Mar 4, 2022
- Review
- 389 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, 9 citing it directly.
- Root · 1 generation backP980025 Logicon Caries DetectorCarestream Dental, LLC · 1998 · Recalled
- This deviceK210365 Second OpinionPearl, Inc. · 2022
- Descendant · cites it directly · 5 of its ownK221921 DTX Studio Clinic 3.0Nobel Biocare AB · 2023
- Descendant · cites it directly · 2 of its ownK231678 Overjet Periapical Radiolucency AssistOverjet, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK231898 DTX Studio Clinic (4.0)Nobel Biocare AB · 2023
- Descendant · cites it directly · 1 of its ownK230144 Denti.AI DetectDenti.Ai Technology, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK260851 Better Diagnostics Dental Assist (BDDA) Version 1.0Better Diagnostics AI Corp. · 2026
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K221921DTX Studio Clinic 3.0Nobel Biocare AB · 2023 · cites it directly5descendants
- K231678Overjet Periapical Radiolucency AssistOverjet, Inc. · 2023 · cites it directly2descendants
- K231898DTX Studio Clinic (4.0)Nobel Biocare AB · 2023 · 2 generations on1descendant
- K230144Denti.AI DetectDenti.Ai Technology, Inc. · 2023 · cites it directly1descendant
- K260851Better Diagnostics Dental Assist (BDDA) Version 1.0Better Diagnostics AI Corp. · 2026 · cites it directly0descendants
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) | K210365 | Second Opinion | Pearl, Inc. | 2022 | — |
| +1 | K221921 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2023 | — |
| +1 | K231678 | Overjet Periapical Radiolucency Assist | Overjet, Inc. | 2023 | — |
| +2 | K231898 | DTX Studio Clinic (4.0) | Nobel Biocare AB | 2023 | — |
| +1 | K230144 | Denti.AI Detect | Denti.Ai Technology, Inc. | 2023 | — |
| +1 | K260851 | Better Diagnostics Dental Assist (BDDA) Version 1.0 | Better Diagnostics AI Corp. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 4 | 0 |
| 2025 | 6 | 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 K222746 Overjet Caries Assistscore 26.4 · 2 generations · 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 4…fication: 21CFR 892.2070, Class II Product Code: MYN 5. Predicate Device Information Predicate device: Logicon Caries Detection by Carestream Dental LLC. (P980025 & Supplements 1, 2, 3 & 4) 6. Device Description Second Opinion® is a computer aided detection ("CADe”) software device indicate… | 1998 |
What descends from it? (12)
See all 129 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221921 | DTX Studio Clinic 3.0 | 2023 | 5 |
| K231678 | Overjet Periapical Radiolucency Assist | 2023 | 2 |
| K230144 | Denti.AI Detect | 2023 | 1 |
| K260851 | Better Diagnostics Dental Assist (BDDA) Version 1.0 | 2026 | 0 |
| K250525 | Second Opinion® Panoramic | 2025 | 0 |
| K243234 | Second Opinion® CS | 2025 | 0 |
| K243893 | Second Opinion® Pediatric | 2025 | 0 |
| K242600 | Second Opinion Periapical Radiolucency Contours | 2025 | 0 |
| K242522 | Second Opinion CC | 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?
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?
Second Opinion® is a computer aided detection ("CADe”) software to identify and mark regions in relation to suspected dental findings which include Caries, Discrepancy at the margin of an existing restoration, Calculus, Periapical radiolucency, Crown (metal, including zirconia & non-metal), Filling (metal & non-metal), Root canal, Bridge and Implants.
It is designed to aid dental health professionals to review bitewing and periapical radiographs of permanent teeth in patients 12 years of age or older as a second reader.
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/K210365 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210365: Second Opinion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210365
Report an extraction error
Are you the manufacturer?
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