Indications for Use
The Yomi platform is cleared by the FDA for use in the United States.
Yomi® is a computerized robotic navigational system intended to provide assistance in both the planning (preoperative) and surgical (intraoperative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides robotic navigational guidance of the surgical instruments. The system can also be used for planning and performing guided bone reduction (also known as alveoplasty) of the mandible and/or maxilla. Yomi is intended for use in partially and fully edentulous adult patients who qualify for dental implants.
When YomiPlan™ software is used for preplanning on third-party PCs, it is intended to perform the planning (preoperative) phase of dental implantation surgery. YomiPlan provides preoperative planning for dental implantation procedures using the Yomi robotic system. The output of YomiPlan is to be used with the Yomi robotic system.
Yomi is not intended for use with patients who have insufficient bone or teeth to retain a Neocis® YomiLink™ rigidly throughout a surgical procedure.