FDA OKs Neocis’ Yomi Dental Robot for Full Arch Implant Treatment

Neocis Inc., a pioneer in robot-assisted dental implant surgery, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new Yomi edentulous indication. 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. The American College of Prosthodontists estimates that over 36 million Americans are missing all their teeth. The new Yomi edentulous splint will enable doctors to use Yomi’s technology to reach more of this population.
 
“I am delighted 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.
 
Dr. Uday Reebye, M.D., DMD, a leader in Oral and Maxillofacial Surgery with a practice in Durham, N.C., was an investigator in the clinical study that supported the FDA clearance. He said, “the advent of Yomi’s full arch protocol is a dramatic shift in dental implant surgery. A reduction in time to surgery, improved surgical efficiency and accuracy combined with a minimally invasive approach have made Yomi’s full arch protocol the gold standard. Using Yomi, I was able to complete full arch surgery on average in 21 minutes.”
 
Dr. Scotty Bolding, DDS, MS, a renowned oral surgeon who practices in both Fayetteville, Ariz. and St. Petersburg/Tampa Bay, Fla., was also an investigator in the clinical study. He 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. 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. 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.”