What is required for the regulatory compliance of AI in dentistry?

Regulatory compliance for AI in dentistry fundamentally hinges on obtaining the necessary approvals from authoritative bodies that ensure safety and efficacy. FDA clearance or CE mark represents a critical step, as these certifications demonstrate that the AI technology has undergone thorough evaluation and meets established standards for medical devices. This compliance is crucial in ensuring that AI applications, such as diagnostic tools or treatment planning systems, are safe for use in a clinical setting.

In contrast, while state dental board approval and certification from professional organizations might be significant for practice standards and professional endorsements, they do not fulfill the specific regulatory requirements mandated for medical devices. Additionally, peer-reviewed publications contribute to the body of knowledge and can support the credibility of an AI solution, but they are not regulatory requirements in themselves. Hence, obtaining FDA clearance or a CE mark is essential for ensuring that the AI application is legally compliant and safe to be utilized in dental practices. This is why it is recognized as the correct answer.