# K232384: Videa Dental Assist

- Pathway: 510(k) (Traditional)
- Applicant: Videahealth, Inc.
- Decided: Dec 15, 2023 after 129 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: 2 generations back to P980025 (1998). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213795: Videa Caries Assist, Videahealth, Inc. (2022) Summary page 6.

## Most influential descendants
- K253009: DS Core Detect (2026), 0 descendants of its own
- K251002: Videa Dental AI (2025), 0 descendants of its own

## Indications for use
Videa Dental Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize the following features. Videa Dental Assist is indicated for the review of bitewing, periapical, and panoramic radiographs acquired from patients aged 3 years or older. Suspected Dental Findings: ● Caries ● Attrition ● Broken/Chipped Tooth ● Restorative Imperfections ● Pulp Stones ● Dens Invaginatus ● Periapical Radiolucency ● Widened Periodontal Ligament ● Furcation ● Calculus Historical Treatments: ● Crown ● Filling ● Bridge ● Post and Core ● Root Canal ● Endosteal Implant ● Implant Abutment ● Bonded Orthodontic Retainer ● Braces Normal Anatomy: ● Maxillary Sinus ● Maxillary Tuberosity ● Mental Foramen ● Mandibular Canal ● Inferior Border of the Mandible ● Mandibular Tori ● Mandibular Condyle ● Developing Teeth ● Erupting Teeth ● Non-matured Erupted Teeth ● Exfoliating Teeth ● Impacted Teeth ● Crowding Teeth

Source page: https://510kreport.com/device/K232384
Methodology: https://510kreport.com/methodology