# K251002: Videa Dental AI

- Pathway: 510(k) (Traditional)
- Applicant: Videahealth, Inc.
- Decided: Sep 19, 2025 after 171 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: 3 generations back to P980025 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232384: Videa Dental Assist, Videahealth, Inc. (2023) Summary page 6.

## Indications for use
Videa Dental AI is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize the following features. Videa Dental AI 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 Imperfection - 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 Tooth - Erupting Teeth - Non-matured Erupted Teeth - Exfoliating Teeth - Impacted Teeth - Crowding Teeth

Source page: https://510kreport.com/device/K251002
Methodology: https://510kreport.com/methodology