Development trend of Artificial Intelligence (AI) in dentistry: exploring FDA-cleared dental devices.

Abstract

Artificial Intelligence (AI) and Machine Learning (ML) are increasingly being incorporated into dentistry to enhance diagnostics, treatment planning, and clinical outcomes. However, their translation into routine practice is contingent upon regulatory approval to ensure safety and effectiveness. In the United States, the Food and Drug Administration (FDA) typically evaluates moderate-risk AI/ML-based dental devices under the 510(k) Premarket Notification pathway. Understanding the approval trend