โก Quick Summary
This study explores the development trends of Artificial Intelligence (AI) in dentistry, focusing on FDA-cleared dental devices. It identifies 52 AI/ML devices, with a notable peak in approvals in 2022, highlighting the need for greater transparency and real-world validation in clinical applications.
๐ Key Details
- ๐ Total devices analyzed: 52 AI/ML dental devices
- ๐ Year with highest approvals: 2022 (nโ=โ8, 15.38%)
- ๐ฆท Primary application: Oral radiology (48%)
- ๐ Countries of origin: USA (46.15%), South Korea (9.61%), Canada (5.76%)
- ๐ Algorithm transparency: 60% did not disclose AI/ML algorithms used
๐ Key Takeaways
- ๐ AI and ML are increasingly integrated into dentistry for improved diagnostics and treatment planning.
- ๐ FDA’s role is crucial in evaluating the safety and effectiveness of AI/ML dental devices.
- ๐ฆท Imaging-based diagnostics dominate the current landscape of FDA-cleared devices.
- ๐ก Overjet, Inc. and Ewoosoft Co., Ltd. are leading companies in this field.
- โ ๏ธ Lack of transparency regarding AI algorithms and clinical deployment is a significant concern.
- ๐ The study emphasizes the need for real-world validation and equitable access to AI technologies in dentistry.
- ๐ Data collection was conducted in December 2024, focusing on the FDA’s 510(k) database.
๐ Background
The integration of Artificial Intelligence (AI) and Machine Learning (ML) into dentistry represents a transformative shift in how dental professionals approach diagnostics and treatment planning. However, the successful implementation of these technologies in clinical practice hinges on obtaining regulatory approval, particularly from the Food and Drug Administration (FDA), to ensure their safety and effectiveness.
๐๏ธ Study
This study involved a comprehensive manual search of the FDA’s 510(k) Premarket Notification Database, focusing on AI/ML devices relevant to dentistry. The researchers extracted data on various parameters, including device type, year of approval, and clinical indications, to assess the trends and characteristics of these innovative technologies.
๐ Results
A total of 52 AI/ML dental devices were identified, with the year 2022 marking a peak in approvals. Nearly half of these devices were indicated for oral radiology, while others focused on implantology and regenerative procedures. Notably, a significant portion of devices lacked transparency regarding the AI algorithms employed and their real-world deployment status.
๐ Impact and Implications
The findings of this study underscore the potential of AI and ML to revolutionize dental practice. However, the lack of transparency and real-world validation poses challenges to their safe adoption. As the field evolves, it is essential to prioritize equitable access and comprehensive documentation to ensure that these technologies can be effectively integrated into routine dental care.
๐ฎ Conclusion
This study highlights the growing role of AI and ML in dentistry, particularly in imaging-based diagnostics. While the advancements are promising, the need for greater transparency and validation remains critical for the successful integration of these technologies into clinical practice. Continued research and regulatory oversight will be vital in shaping the future of AI in dentistry.
๐ฌ Your comments
What are your thoughts on the integration of AI in dentistry? Do you believe that transparency and validation are adequately addressed in current practices? ๐ฌ Share your insights in the comments below or connect with us on social media:
Development trend of Artificial Intelligence (AI) in dentistry: exploring FDA-cleared dental devices.
Abstract
INTRODUCTION: 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 trends and characteristics of these devices is crucial for assessing the clinical integration of AI in dentistry.
MATERIALS AND METHODS: A manual search of the FDA’s 510(k) Premarket Notification Database was conducted in December 2024 using the terms “AI/ML devices” and “dentistry.” Devices were screened for relevance, and data were extracted regarding applicant name, device type, predicate device, year of approval, AI algorithm employed, clinical indication, country of origin, and status of real-world deployment.
RESULTS: Fifty-two AI/ML dental devices were identified. The year 2022 saw the highest number of approvals (nโ=โ8, 15.38%). Nearly half (nโ=โ25, 48%) of the devices were indicated for oral radiology, followed by applications in implantology and regenerative procedures (nโ=โ18, 32%). Overjet, Inc. received four approvals for diagnostic tools targeting caries, calculus, and charting. Ewoosoft Co., Ltd. accounted for six approvals, primarily versions of its Ez3D-i imaging platform. Most devices originated from the United States (nโ=โ24, 46.15%), followed by South Korea (nโ=โ5, 9.61%) and Canada (nโ=โ3, 5.76%). Notably, 60% of devices did not disclose the type of AI/ML algorithm used (nโ=โ31), and 50% lacked public documentation on clinical deployment (nโ=โ26).
CONCLUSION: Most FDA-cleared AI/ML dental devices in the 510(k) database are imaging-based diagnostics; greater transparency, real-world validation, and attention to equity are needed for safe adoption.
Author: [‘Naved N’, ‘Adnan S’, ‘Umer F’]
Journal: BMC Oral Health
Citation: Naved N, et al. Development trend of Artificial Intelligence (AI) in dentistry: exploring FDA-cleared dental devices. Development trend of Artificial Intelligence (AI) in dentistry: exploring FDA-cleared dental devices. 2025; (unknown volume):(unknown pages). doi: 10.1186/s12903-025-07302-6