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

Area of Science:

• Dentistry
• Medical Imaging
• Artificial Intelligence

Background:

• Artificial Intelligence (AI) and Machine Learning (ML) are increasingly integrated into dentistry for improved diagnostics and treatment planning.
• Regulatory approval, particularly through the U.S. Food and Drug Administration (FDA) 510(k) pathway, is essential for the safe and effective clinical adoption of AI/ML dental devices.

Purpose of the Study:

• To analyze the trends and characteristics of AI/ML-based dental devices approved by the FDA.
• To understand the landscape of AI/ML dental technology integration into clinical practice.

Main Methods:

• A manual search of the FDA's 510(k) Premarket Notification Database was performed in December 2024.
• Keywords used included "AI/ML devices" and "dentistry," with data extracted on device type, approval year, clinical indication, and origin.

Main Results:

• Fifty-two AI/ML dental devices were identified, with the highest number of approvals in 2022 (15.38%).
• Oral radiology (48%) dominated device indications, followed by implantology and regenerative procedures (32%).
• Most devices originated from the U.S. (46.15%), but a significant portion (60%) did not disclose the AI/ML algorithm, and 50% lacked public deployment data.

Conclusions:

• The majority of FDA-cleared AI/ML dental devices are for imaging diagnostics.
• Increased transparency regarding algorithms and robust real-world validation are crucial for the safe integration of AI in dentistry.
• Consideration of equity is necessary for the widespread adoption of AI/ML dental technologies.