# K213795: Videa Caries Assist

- Pathway: 510(k) (Traditional)
- Applicant: Videahealth, Inc.
- Decided: Apr 21, 2022 after 136 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.
9 later devices descend from it; 2 cite it directly.
0 of 11 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
- K232384: Videa Dental Assist (2023), 2 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
- K252934: Diagnocat (2026), 0 descendants of its own

## Indications for use
Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize carious lesions. Videa Caries Assist is indicated for use by board licensed dentists for the concurrent review of bitewing (BW) radiographs acquired from adult patients aged 22 years or older.

Source page: https://510kreport.com/device/K213795
Methodology: https://510kreport.com/methodology