# K210365: Second Opinion

- Pathway: 510(k) (Traditional)
- Applicant: Pearl, Inc.
- Decided: Mar 4, 2022 after 389 days
- Product code: MYN (Analyzer, Medical Image)
- Device class: 2
- Regulation: 21 CFR 892.2070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P980025 (1998). 1 ancestor in all.
12 later devices descend from it; 9 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P980025: Logicon Caries Detector, Carestream Dental, LLC (1998) Summary page 4.

## Most influential descendants
- K221921: DTX Studio Clinic 3.0 (2023), 5 descendants of its own
- K231678: Overjet Periapical Radiolucency Assist (2023), 2 descendants of its own
- K231898: DTX Studio Clinic (4.0) (2023), 1 descendant of its own
- K230144: Denti.AI Detect (2023), 1 descendant of its own
- K260851: Better Diagnostics Dental Assist (BDDA) Version 1.0 (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K210365
Methodology: https://510kreport.com/methodology