Cube Click, Inc. Secures FDA Approval for SMILE Dx—A Game-Changer in Dental AI Diagnostics

FDA clearance positions SMILE Dx as a pioneering AI-powered platform for early detection and diagnosis in dental care, streamlining clinical workflows and improving patient outcomes.

Cube Click, Inc. has secured FDA approval for SMILE Dx®, a next-generation AI-powered diagnostic platform designed to transform dental radiography and decision-making. As the first and only FDA-cleared dental AI device compatible with both digital and phosphor plate sensors, SMILE Dx uses advanced image analysis to detect cavities, root canal infections, and periodontal disease at the pixel level. This breakthrough addresses the longstanding challenge of diagnostic variability in dentistry, where over 20% of carious lesions and root canal pathologies are routinely missed, according to FDA data.

Clinically, SMILE Dx offers a substantial leap forward in diagnostic accuracy, workflow efficiency, and patient engagement. Multiple studies show that the system delivers a 19% average improvement in diagnostic detection, enabling dentists to more confidently identify and treat oral conditions. The platform supports earlier intervention, fewer missed diagnoses, and stronger patient communication—leading to improved treatment acceptance and outcomes. Because it is cloud-based, SMILE Dx integrates seamlessly into existing practice systems and provides a scalable, real-time solution for dental professionals seeking to elevate the standard of care.

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