Overjet Dental Assist
Overjet, Inc.Overjet Dental Assist is a software designed to assist dental professionals by semi-automatically measuring bone levels on dental bitewing and periapical radiographs. It helps by automating the measurement process to support diagnosis and treatment planning but is not intended to replace full patient evaluation or diagnosis by professionals.
Intended Use
Overjet Dental Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs.
Technology
A cloud native Software as a Medical Device that automates the measurement of interproximal bone levels from dental bitewing and periapical radiographs, allowing users to view, review, and modify associated annotations.
Performance
Software verification and validation were performed with bench and clinical testing. Bench testing included evaluation of 2234 bitewing and 6543 periapical radiographs with high precision and recall metrics. Clinical testing used retrospective data from 65 bitewing and 96 periapical radiographs, showing sensitivity >85%, specificity around 95%, and mean absolute differences within clinically acceptable ranges. No adverse events were reported.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/25/2021
3 months - 2
FDA Approval
5/19/2021
Other devices from Overjet, Inc.
- Overjet Image Enhancement Assist2024 • 510K
- Overjet Charting Assist2024 • 510K
- Overjet Caries Assist-Pediatric2024 • 510K
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