Denti.AI Detect Receives FDA 510(k) Clearance

Denti.AI, a trailblazer in harnessing Artificial Intelligence for dental pathology detection, odontogram automation, and periodontal charting, proudly announces a significant milestone. 

The FDA has granted 510(k) clearance for their innovative product, Denti.AI Detect. This state-of-the-art imaging solution is poised to assist dental professionals in identifying prevalent dental diseases such as caries, periapical lesions, and bone loss from dental x-rays. Clinical studies have demonstrated an impressive 26% increase in disease detection, offering dental practitioners new treatment opportunities with Denti.AI Detect.

Synergy with Denti.AI Auto-Chart

Building on the success of Denti.AI Auto-Chart, which gained FDA clearance in November 2022 for automating odontogram charting, Denti.AI Detect now seamlessly integrates with Auto-Chart. This synergy enhances disease charting and treatment plan coding within multiple integrated Practice Management Systems (PMS). The amalgamation of these two technologies signifies a significant leap forward in streamlining dental practice workflows and elevating patient care.

FDA clears AI-powered Denti.AI Auto-Chart

Industry-First FDA Clearance for Disease Detection on Panoramic Images

A standout feature of Denti.AI Detect is its industry-first FDA clearance for disease detection on panoramic images. Denti.AI becomes the sole dental AI company to have obtained FDA clearance for all three major dental concerns: caries, periapical radiolucencies, and bone levels. This achievement marks a monumental step in the dental technology landscape.

Before receiving FDA clearance, Denti.AI Detect had already earned licensing from Canada Health and was extensively employed in multiple Canadian dental practices. This practical utility and reliability further validate its effectiveness.

Denti.AI’s founder and CEO, Dmitry Tuzoff, expressed his gratitude for the tireless dedication of his team, highlighting the significance of panoramic imaging technology in propelling their product to the forefront. This innovation aligns with the growing usage of panoramic imaging practices across North America.

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About Denti.AI

Established in 2017, Denti.AI utilises AI to interpret pathologies, past treatments, and anatomical features from dental x-rays and voice commands. This facilitates early disease detection, enhances productivity for dentists and hygienists, and ensures 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, with hundreds of active users. 

For more information, visit www.denti.ai