Denti.AI Detect
Denti.AI Technology, Inc.Denti.AI Detect is a computer-assisted detection software designed for dental professionals to assist in identifying dental issues such as caries and periapical radiolucency on 2D dental X-rays. It also helps measure bone levels around teeth, serving as a second reader to improve diagnostic accuracy and support clinical decisions.
Intended Use
Software device for dental professionals to assist in detecting and highlighting caries and periapical radiolucency and measuring bone levels on 2D dental radiographs for patients 22 years and older.
Technology
Cloud-based AI software analyzing intraoral and extraoral 2D dental radiographs to detect caries and periapical radiolucency and measure mesial and distal bone levels of teeth using image processing and pattern recognition algorithms.
Performance
Software verification and validation were performed per FDA guidance. Clinical performance was tested on 709 images for detection and 193 images for bone measurement, showing sensitivity above 90% for bone levels and improved reader performance with statistical significance. Results met acceptance criteria except for a minor exception in specificity on periapical images.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/18/2023
8 months - 2
FDA Approval
10/6/2023
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