Dental robotics company Neocis has received FDA 510(k) clearance for its Yomi S robotic system and YomiPlan software to support pterygoid implant placement.
This is the first and only U.S. FDA clearance for digital guided surgery for pterygoid implants, according to an Oct. 29 news release.
Neocis said it ran a formal verification and validation program confirming Yomi S maintains its accuracy specifications for pterygoid procedures. Human factors validation also found the procedure safe and effective when performed by trained dental professionals with no additional robotic training beyond the user manual.
The clearance adds to the robotic system’s existing indications for single-tooth, multiple-tooth, full-arch and dual-arch procedures and guided alveoplasty. More than 125,000 implants have been placed with Yomi robotic assistance to date.
