AI and the FDA Regulatory Landscape

— FDA regulatory pathways for AI/ML medical devices: 510(k) clearance, De Novo classification, and PMA approval

— The regulatory pathway most commonly used by dental AI/ML products

— Current landscape of FDA-cleared dental AI/ML products and the growth of the field

— What FDA clearance means for a dental AI product and what it does not guarantee about performance in individual clinical practice

— Clinical validation, intended use, and the importance of independent evaluation before integrating AI tools into practice.