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Medical Devices / Submissions and Approvals

FDA Clears Additional Dental Materials for Neocis’ Yomi System

Jan. 9, 2019

The FDA granted 510(k) clearance for additional dental materials to be used with Neocis’ Yomi device, a robotically-assisted dental surgery system that constrains the drill’s position, orientation and depth.

The company previously received clearance from the FDA in February 2018 for a chairside splint to be used with the system, which uses the robot-assisted guidance to help complete the implant surgery in a single visit.

The device offers computerized navigation to help surgeons during the pre-surgical planning and surgical stages of dental implantation.

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