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Medical Devices / Submissions and Approvals

FDA Clears Additional Dental Materials for Neocis’ Yomi System

Jan. 9, 2019
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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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