Neocis Announces FDA 510(k) Clearance of Additional Dental Materials for Use with Yomi®
New materials provide important enhancements to robot-assisted dental implant surgery workflow
Miami, FL, [January 7, 2019] — Neocis, Inc., the leader and innovator in dental implant surgery using advanced robotics, today announced a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for additional dental materials to use with Yomi. This clearance will expand workflow options to dental surgeons to achieve robot-assisted guidance.
Yomi, the first and only FDA cleared robot-assisted dental surgery system, provides computerized navigation to assist in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system offers physical guidance through haptic robotic technology, which constrains the drill in position, orientation, and depth. The assistive technology provides the surgeon with complete control and, unlike plastic surgical guides, allows for clear visualization of the surgical site.
Alon Mozes, PhD, Chief Executive Officer of Neocis stated, “Workflow options enabled by this new clearance offers more flexibility in the implementation of robot-assisted dental surgery and helps us to expand our reach to the more than four million dental implants performed in the U.S. each year. Workflow enhancements enabled by this new clearance are a direct result of our corporate commitment to the voice of the customer.”
“It has been great to work with Neocis as a Pioneer. This latest FDA clearance helps to provide me with even more workflow options for incorporating Yomi into my practice,” says Dr. Uday Reebye, oral surgeon in North Carolina and Yomi pioneer user.
Neocis previously received FDA clearance in February 2018 for a Chairside Splint to be used with Yomi, which enabled a same-day workflow that facilitated completion of dental implant surgery with robot-assisted guidance in a single visit.
About Neocis, Inc.
Neocis® is a private company located in Miami, Florida that is transforming dental implant surgery with advanced robotics, with a vision of advancing healthcare through the latest technology. The company’s FDA cleared Neocis Guidance System, or Yomi®, is indicated for use to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. Yomi® provides surgical guidance through the use of haptic robotic technology, software, and multisensory feedback to help achieve the right position, angulation, and depth to place the implant exactly according to plan. Yomi® enables a minimally invasive flapless approach, which has been proven to lead to faster surgery, faster recovery, and less pain for the patient. Learn more at www.neocis.com.
Leigh Salvo or Carrie Mendivil