FDA-Approved AI Solutions in Dental Imaging: A Narrative Review of Applications, Evidence, and Outlook.

INTRODUCTION AND

aimsArtificial intelligence (AI) has rapidly transformed dental imaging by enabling automated detection, diagnosis, and analysis of various dental conditions. However, a comprehensive synthesis of United States Food and Drug Administration (FDA)-cleared, clinically validated AI solutions in dental imaging remains limited. This review aims to catalog all standalone, cloud-based dental AI platforms with FDA clearance, highlighting their clinical applications, performance outcomes, and supporting evidence to guide evidence-based integration.

methodsA two-phase systematic search was conducted. In the first phase, searches of U.S. FDA regulatory databases (510[k], De Novo, and PMA) were performed through July 2025 to identify standalone, cloud-based dental AI imaging devices cleared or authorized for autonomous or semi-autonomous analysis. In the second phase, PubMed, Web of Science, and Google Scholar were systematically searched to retrieve studies assessing the performance or clinical utility of the identified platforms. Two independent reviewers performed data screening and extraction, with discrepancies resolved by a third reviewer.

resultsThirteen companies were identified as offering twenty-nine FDA-cleared AI products for dental imaging. These solutions addressed diverse clinical tasks, including caries detection, periodontal disease assessment, cephalometric analysis, multi-pathology diagnostics, automated dental charting, and three-dimensional segmentation. Performance outcomes reported by the FDA demonstrated high accuracy, sensitivity, and specificity across most platforms, particularly for caries detection, periodontal disease measurement, and cephalometric analysis. Among these, Relu Creator and WebCeph were supported by the highest number of peer-reviewed publications, whereas several newer platforms lacked independent clinical validation.

conclusionStandalone, FDA-cleared AI platforms represent a paradigm shift in dental imaging, providing clinically validated tools for diagnosis, treatment planning, and patient monitoring. By systematically cataloging these solutions, this review delivers an evidence-based reference for clinicians and researchers, supporting informed adoption and identifying areas for future investigation.