Neocis announced today that it filed for FDA 510(k) clearance for its Yomi edentulous splint to aid its dental robotic surgical system.
The Miami-based company’s new splint is designed to enable the Yomi dental robotic system to go beyond placing implants for partially edentulous patients, with new capabilities for assisting doctors with full arch implant cases, according to a news release. The edentulous splint is set to help restore the dentition and smiles of people who are missing their teeth.
Yomi is touted as the first and only FDA-cleared robot-assisted dental surgery system, as it is indicated for use in the pre-operative and intra-operative phases of dental implantation surgery. The system offers computerized navigation and physical guidance through haptic robotic technology and has been used to place over 1,800 dental implants in the U.S.
President & CEO Alon Mozes said in the release that Yomi’s 510(k) clearance filing comes on the back of a successful clinical study of the edentulous splint.
“Since there is no plastic surgical guide needed, there was no wait for surgical guide fabrication, and no physical guide impeding access or visualization,” the study’s lead investigator Dr. Uday Reebye said. “Given the accuracy, precision, and intraoperative flexibility of robotic surgical platforms, this preliminary data supports the promise of Yomi robotic guidance to augment dental implant therapy for fully edentulous arches.”
Original Article: (https://www.massdevice.com/neocis-seeks-510k-nod-for-yomi-edentulous-splint-for-robotic-dental-surgery/)
