Denti.AI announces the groundbreaking FDA 510(k) clearance of Denti.AI Detect, a revolutionary AI-powered imaging solution, amplifying disease detection capabilities in intra- and extraoral dental radiography and charting automation.

Denti.AI, a pioneer in leveraging Artificial Intelligence for dental pathology detection, odontogram and periodontal charting automation, proudly announces the 510(k) clearance by the FDA of its innovative product, Denti.AI Detect. This state-of-the-art imaging solution is engineered to aid dental professionals in identifying prevalent dental diseases such as caries, periapical lesions, and bone loss from dental x-rays. Clinical studies reveal a notable enhancement in disease detection by all the two dozen participating dentists, unlocking 26% extra treatment opportunities with Denti.AI Detect.

Following the prior clearance of Denti.AI Auto-Chart in November 2022, a breakthrough in automating odontogram charting of restorations, root canals, implants, crowns, and missing teeth, Denti.AI Detect now integrates with Auto-Chart to further refine disease charting and treatment plan coding in multiple integrated Practice Management Systems (PMS). This integration manifests a significant stride towards optimizing dental practice workflows and enhancing patient care.

A key distinguishing feature of Denti.AI Detect is its industry-first FDA clearance for disease detection on panoramic images. Denti.AI also stands as the only dental AI company to have secured clearance for all three major dental concerns: caries, periapical radiolucencies, and bone levels, marking a monumental achievement in the dental technology landscape.

Table 1 Comparison of Denti.AI Imaging Products with Other AI-First Companies Based on FDA Clearance Documents

Dr. Edward Gelfand, owner of over 30 dental practices and partner of the largest Canadian DSO, extolled the effectiveness of Denti.AI Detect saying, "The ability of Denti.AI Detect to uncover missed diseases has been a game-changer in not only identifying treatment opportunities but also in educating our patients. Our best dentists attest to the indispensable nature of this tool in their practice."

Before its FDA clearance, Denti.AI Detect had already been licensed by Canada Health and extensively employed across multiple dental practices in Canada, further demonstrating its practical utility and reliability.

Dr. Jonathan B. Levine, owner of the prestigious multi-specialty clinic JBL NYC and Chairman/Founder of innovative dental technology company GLOScience, shared his positive experience, "After the rigorous research of Denti.AI Detect in our clinic over many months, I am thrilled to finally become a customer. The technology has proven itself invaluable."

Denti.AI Founder and CEO, Dmitry Tuzoff, reflected on the journey, "The realization of Denti.AI Detect clearance signifies countless hours of dedication from our team. The introduction of panoramic imaging technology, especially, propels our product to the forefront, addressing the growing usage of such imaging practices across North America."

As part of its launch celebration, Denti.AI is offering special pricing terms for Denti.AI Detect & Auto-Chart until the end of the year. Interested parties are encouraged to explore this opportunity by filling out the form at www.denti.ai.