Smile Dx®
Cube Click, Inc.Smile Dx® is an AI-powered software that assists dentists by analyzing dental X-ray images to detect issues like cavities, periapical radiolucencies, restorations, and measures bone levels. It supports digital and phosphor sensors, enhancing diagnosis and treatment planning by highlighting suspected dental findings for review, but it does not replace a dentist's judgment.
Intended Use
Smile Dx® is a computer-assisted detection (CADe) software designed to aid dentists in reviewing digital bitewing and periapical radiographs of permanent teeth to detect and segment suspected dental findings including caries, periapical radiolucencies, restorations, and dental anatomy and to aid in bone level measurements.
Technology
Smile Dx® is a SaMD computer-assisted detection device using machine learning algorithms to analyze dental radiographs; it supports images from various radiography devices and uses a three-layer architecture for image ingestion, detection and measurement, and visualization via a web-based user interface.
Performance
Performance testing included standalone evaluation on datasets of dental images for detecting caries and periapical radiolucencies, bone level measurement, and anatomy/restoration detection, showing high sensitivity and specificity. Multi-reader multi-case (MRMC) clinical evaluations demonstrated significant reader performance improvements with Smile Dx®. Software verification and validation were performed as per FDA guidance for device software.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/16/2024
9 months - 2
FDA Approval
5/14/2025
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