Envista Obtains FDA Clearance for Its Mandibular Nerve Tracing Software

Envista has received the FDA’s 510(k) clearance for a new feature of its DTX Studio Clinic image acquisition and diagnostic platform that enables dentists to trace the mandibular nerve.

This is the DTX platform’s third marketing clearance form the agency. In 2017, Envista obtained FDA clearance for its artificial intelligence-driven 3D virtual tooth setup algorithm. And the company received a second clearance in 2020 for the software’s automatic tooth position identification and automated sorting of full-mouth X-ray series.

The tracing of the mandibular nerve helps clinicians to identify the best available therapeutic options for patients, the Brea, Calif.-based company said.