Denti.AI Revolutionizes Pathology Detection with FDA Clearance for Denti.AI Detect


The company receives 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 Revolutionizes Pathology Detection with FDA Clearance for Denti.AI Detect | Image Credit: © Denti.AI

Denti.AI Revolutionizes Pathology Detection with FDA Clearance for Denti.AI Detect | Image Credit: © Denti.AI

Denti.AI, a trailblazer in the realm of artificial intelligence- (AI-) driven dental pathology detection, odontogram, and periodontal charting automation, today announced the monumental achievement of securing FDA 510(k) clearance for its groundbreaking product, Denti.AI Detect. This state-of-the-art AI-powered imaging solution is set to redefine disease detection capabilities in both intraoral and extraoral dental radiography, while also automating charting processes.

Denti.AI Detect has been designed to empower dental professionals with the ability to identify prevalent dental diseases, such as caries, periapical lesions, and bone loss, using dental x-rays. Extensive clinical studies with the participation of over 2 dozen dentists have demonstrated a notable enhancement in disease detection, unlocking an impressive 26% increase in treatment opportunities when using Denti.AI Detect.

This milestone follows the successful clearance of Denti.AI Auto-Chart in November 2022, a breakthrough in automating odontogram charting for various dental procedures, including restorations, root canals, implants, crowns, and missing teeth. Denti.AI Detect seamlessly integrates with Auto-Chart to further streamline disease charting and treatment plan coding in multiple integrated practice management systems. This integration marks a significant stride towards optimizing dental practice workflows and enhancing patient care.

One of the key distinguishing features of Denti.AI Detect is its industry-first FDA clearance for disease detection on panoramic images, a significant advancement in dental radiography. Denti.AI holds the unique distinction of being the only dental AI company to have secured clearance for all 3 major dental concerns: caries, periapical radiolucencies, and bone levels, making it a transformative player in the dental technology landscape, according to the company.

Edward Gelfand, DDS, owner of over 30 dental practices and a partner of the largest Canadian Dental Service Organization (DSO), praised the effectiveness of Denti.AI Detect, saying in a press release, "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 receiving FDA clearance, Denti.AI Detect had already obtained licensing from Canada Health and had been extensively utilized across multiple dental practices in Canada, underscoring its practical utility and reliability. Jonathan B. Levine, DMD, owner of the prestigious multi-specialty clinic JBL NYC and chairman/founder of innovative dental technology company GLOScience, shared his positive experience, stating in the press release, "After 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's Founder and CEO, Dmitry Tuzoff, reflected on the journey, stating in the press release, "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."

To celebrate this big achievement, Denti.AI is offering special pricing terms for Denti.AI Detect and Auto-Chart until the end of the year. Interested parties are encouraged to explore this opportunity by filling out the form at

Established in 2017, Denti.AI employs AI to decipher pathologies, past treatments, and anatomical features from dental x-rays and voice commands, facilitating early disease detection, enhancing productivity for dentists and hygienists, and ensuring accurate record-keeping. Integrated with practice management systems, Denti.AI's imaging and voice AI products are automating workflows for dental groups across North America, boasting hundreds of active users.

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