# K230144: Denti.AI Detect

- Pathway: 510(k) (Traditional)
- Applicant: Denti.Ai Technology, Inc.
- Decided: Oct 6, 2023 after 261 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: 9 generations back to K930527 (1993). 12 ancestors in all.
1 later device descends from it; 1 cites 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)
- K210365: Second Opinion, Pearl, Inc. (2022) Summary page 4.
- K210187: Overjet Dental Assist, Overjet, Inc. (2021) Summary page 4.

## Most influential descendants
- K250525: Second Opinion® Panoramic (2025), 0 descendants of its own

## Indications for use
Denti.AI Detect is a Computer-Assisted Detection (CADe) software device intended to be used by dental professionals, comprising dentists and dental specialists, while reading extraoral and intraoral 2D dental radiographs. The device aims to assist in detecting and highlighting uncategorized regions of interest (ROIs) within the teeth area, which include caries and periapical radiolucency, as a second reader. The device is also intended to aid in the measurements of mesial and distal bone levels associated with each tooth. The device is aimed to be used with images from the patients of 22 years age and older without remaining primary dentition. The device is not intended to replace a complete clinician's review or clinical judgment that considers other relevant information from the image or patient history.

Source page: https://510kreport.com/device/K230144
Methodology: https://510kreport.com/methodology