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

TL;DR

This paper reviews FDA-approved AI tools for dental imaging, summarizing their uses, performance, and evidence to help guide their clinical adoption.

Contribution

The paper provides the first comprehensive catalog of FDA-cleared, cloud-based AI platforms for dental imaging with clinical validation.

Findings

Thirteen companies offer 29 FDA-cleared AI products for diverse dental imaging tasks.

Performance metrics like accuracy and sensitivity are high for caries detection and periodontal disease measurement.

Relu Creator and WebCeph have the most peer-reviewed support, while newer platforms lack validation.

Abstract

Artificial 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.

A 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.

Thirteen 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.

Standalone, 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.

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