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Robotics company Neocis, Inc., has received FDA 510(k) clearance for a new Yomi® edentulous indication.
Robotics company Neocis, Inc., has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new Yomi® edentulous indication, the company announced in a press release. The clearance allows for a new splint attachment which broadens Yomi’s application to include full arch implant cases, as well as partially edentulous cases.
“I am delighted today to report that we have received 510(k) clearance for Yomi to assist with full arch implant surgeries. With this clearance, Yomi doctors will be able to leverage robotic technology to treat more patients and restore more smiles” said Alon Mozes, Ph.D., CEO of Neocis.
The American College of Prosthodontists estimates that over 36 million Americans are missing all their teeth. The new Yomi edentulous splint will allow doctors to use Yomi’s technology to reach more of this population.
Yomi is the first and only FDA-cleared robot-assisted dental surgery system. It’s a computerized navigational system intended to provide assistance in both the planning and the surgical phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. For more information, visit neocis.com.