PMA · Approved
Recalled · Class II · 2015Logicon Caries Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carestream Dental, LLC · MYN Analyzer, Medical Image
Approved on Sep 25, 1998 through premarket approval, which rests on the device’s own clinical evidence after a 99-day review. 28 later devices descend from it. It has been recalled once.
- Decided
- Sep 25, 1998
- Review
- 99 days
- Class
- Class II
- Product code
- MYN
- Recalls
- 1
28 later devices descend from it, 4 citing it directly.
- This deviceP980025 Logicon Caries DetectorCarestream Dental, LLC · 1998
- Descendant · cites it directly · 12 of its ownK212519 Overjet Caries AssistOverjet, Inc. · 2022
- Descendant · cites it directly · 12 of its ownK210365 Second OpinionPearl, Inc. · 2022
- Descendant · 2 generations on · 9 of its ownK222746 Overjet Caries AssistOverjet, Inc. · 2023
- Descendant · cites it directly · 9 of its ownK213795 Videa Caries AssistVideahealth, Inc. · 2022
- Descendant · 2 generations on · 5 of its ownK221921 DTX Studio Clinic 3.0Nobel Biocare AB · 2023
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K212519Overjet Caries AssistOverjet, Inc. · 2022 · cites it directly12descendants
- K210365Second OpinionPearl, Inc. · 2022 · cites it directly12descendants
- K222746Overjet Caries AssistOverjet, Inc. · 2023 · 2 generations on9descendants
- K213795Videa Caries AssistVideahealth, Inc. · 2022 · cites it directly9descendants
- K221921DTX Studio Clinic 3.0Nobel Biocare AB · 2023 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P980025 | Logicon Caries Detector | Carestream Dental, LLC | 1998 | — |
| +1 | K212519 | Overjet Caries Assist | Overjet, Inc. | 2022 | — |
| +1 | K210365 | Second Opinion | Pearl, Inc. | 2022 | — |
| +2 | K222746 | Overjet Caries Assist | Overjet, Inc. | 2023 | — |
| +1 | K213795 | Videa Caries Assist | Videahealth, Inc. | 2022 | — |
| +2 | K221921 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 4 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 11 | 0 |
| 2026 | 5 | 0 |
Sources: FDA PMA database (decision fields and supplements), 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (28)
See all 284 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 6, 2015 | Class II | Z-1537-2015 | Unknown/Undetermined by firm | GA Industries is recalling the Logicon Caries Detector, version 5.0, for Carestream Dental because it was not submitted for approval to the FDA prior to product release. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K212519 (Overjet, Inc., 2022) has gone furthest, with 12 descendants of its own.
How does its category compare?
All MYN devicesMYN Analyzer, Medical Image: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/P980025 · printed Nov 6, 2026
Cite this page
510(k) Report. “P980025: Logicon Caries Detector.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P980025
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026