Clearance pathways and intended uses of FDA-authorized artificial intelligence devices in dentistry, 2018-2025

Rigel Ramirez Fritze and Rigelramirezf1021@gmail.com

SAP Artificial Intelligence in Dentistry, 2025

Abstract: Introduction: Artificial intelligence-enabled dental devices are entering clinical practice through regulatory authorization by the US Food and Drug Administration (FDA), but the pathways and intended uses that characterize them have not been summarized for the dental field. Methods: We identified AI-enabled dental devices in the FDA list of artificial intelligence and machine learning-enabled medical devices with a final decision from 2018 to 2025, and characterized their clearance pathways, intended uses, and validation evidence using the FDA list and openFDA 510(k) records. Results: Fourteen AI-enabled dental devices were authorized, of which 13 (92.9%) were cleared through the 510(k) pathway and one through the De Novo pathway. All 13 510(k) devices used the traditional clearance type with a substantially equivalent decision, and none used third-party review. Devices addressed caries detection (n = 5), dental radiograph analysis (n = 6), orthodontic monitoring (n = 1), orthodontic software (n = 1), and surgical navigation (n = 1). Ten devices were reviewed under the Radiology panel and four under the Dental panel. Conclusions: AI-enabled dental devices are authorized predominantly through the traditional 510(k) pathway with substantial equivalence, concentrated in dental radiograph analysis and caries detection.

Date: 2025
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Persistent link: https://EconPapers.repec.org/RePEc:cwf:aidart:aid202538

DOI: 10.62486/aid202538

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