10 April 2022

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Envista wins FDA nod for mandibular nerve tracing

Katherine E. Pfaff

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Dental and orthodontics company, Envista Holdings Corporation, has won FDA clearance for its AI mandibular nerve tracing technology. The 510(k) clearance applies to the company’s artificial intelligence mandibular nerve tracing that is an important part of its diagnostic and image acquisition software, DTX Studio Clinic. 

“This clearance is another important step toward our digital strategy of expanding the capabilities of our powerful, unified, and open dental diagnostic software platform DTX Studio Clinic,” said Amir Aghdaei, chief executive officer of Envista. “With its combination of a user-friendly interface and AI-driven functionality, DTX Studio Clinic reduces the time clinicians spend on time-consuming tasks, while simultaneously helping prevent complications and enabling increased focus on the patient. We are particularly proud of our fully automated mandibular nerve tracing functionality with its high clinical relevance for dental implant-based patient rehabilitations.”

The technology can add to visualization of the mandibular nerve which is important in order to avoid unintended complications and to broaden the treatment options for each patient. Without the new tool, dentists are often locating the mandibular nerve manually, which can add to treatment time and may be inaccurate. 

The company previously obtained FDA clearance for its software’s identification of tooth position and in sorting of x-rays of the mouth. The mandibular nerve tracing tool previously won clearance when used with CBCT scans. 

Source: https://www.prnewswire.com/news-releases/envista-obtains-fda-clearance-for-assisted-intelligence-mandibular-nerve-tracing-301512290.html