Dental technology company, Neocis, Inc., has filed for 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new Yomi® edentulous splint. This new splint will allow the Yomi system to go beyond the placement of implants on partially edentulous patients to assist doctors with full arch implants.
The American College of Prosthodontists estimates that over 36 million Americans are missing all of their teeth. The new Yomi edentulous splint will enable doctors to use Yomi’s technology to help restore the dentition and smiles of people who are missing their teeth.
“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.
Dr. Uday Reebye, MD, DMD, a leader in Oral and Maxillofacial Surgery, who was the lead investigator in the Yomi Edentulous splint’s clinical study said, “Since there is no plastic surgical guide needed, there was no wait for surgical guide fabrication, and no physical guide impeding access or visualization. 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 fully edentulous arches.”
Dr. Scotty Bolding, DDS, MS, a nationally recognized leader in Oral and Maxillofacial Surgery, who was an investigator in the Yomi Edentulous splint’s clinical study 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.”