# P980025: Logicon Caries Detector

- Pathway: PMA
- Applicant: Carestream Dental, LLC
- Decided: Sep 25, 1998 after 99 days
- Product code: MYN (Analyzer, Medical Image)
- Device class: 2
- Regulation: 21 CFR 892.2070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
28 later devices descend from it; 4 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K212519: Overjet Caries Assist (2022), 12 descendants of its own
- K210365: Second Opinion (2022), 12 descendants of its own
- K222746: Overjet Caries Assist (2023), 9 descendants of its own
- K213795: Videa Caries Assist (2022), 9 descendants of its own
- K221921: DTX Studio Clinic 3.0 (2023), 5 descendants of its own

## Recalls of this device
- Apr 6, 2015 · Class II · Z-1537-2015: 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.

Source page: https://510kreport.com/device/P980025
Methodology: https://510kreport.com/methodology