Neocis has filed for 510(k) clearance from the Food and Drug Administration for an edentulous splint that will enable its Yomi Dental Robotic system to go beyond placing implants on partially edentulous patients to assisting doctors with full-arch implant cases.
“Our doctors have been asking for a splint that would enable Yomi to assist with restoring full arches. After the conclusion of a successful clinical study of our new edentulous splint, I am delighted today to report that we have filed for 510(k) clearance,” said Alon Mozes, PhD, chief executive officer and president of Neocis.
“Since there is no plastic surgical guide needed, there was no wait for surgical guide fabrication, and no physical guide impeding access or visualization,” said Uday Reebye, MD, DMD, an oral and maxillofacial surgeon who was the lead investigator in Neocis’ clinical study of the splint.
“Robotic haptic guidance securely constrained the handpiece to the virtual restorative plan. 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 full edentulous arches,” Reebye said.
“I was so impressed by the accuracy of the first cases using Yomi robotic guidance in fully edentulous patients. The splints were extremely stable, easy to use, and remarkably accurate,” said Scotty Bolding, DDS, MS, an oral and maxillofacial surgeon who also was an investigator in the clinical study of the splint.
“Additionally, there was excellent visibility in the surgical field that you cannot get with any available guide today. There is no doubt in my mind that Yomi will set the standard for the multi-implant cases in the future,” said Bolding. “I have been placing dental implants for over 30 years and I have never experienced the precision or accuracy that was demonstrated with the new full-arch splint.”
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