Yomi Robotic System

The Yomi Robotic System is a computerized robotic navigational system that assists in planning and performing dental implant surgery. It uses pre-operative planning software (YomiPlan) based on cone beam CT scans to create a 3D model of patient anatomy, then provides real-time guidance to the surgeon during implant placement and bone reduction procedures. The system is intended for use in partially or fully edentulous adult patients qualifying for dental implants.

The subject device adds automatic segmentation algorithms (from Relu Creator) for maxillary sinuses, inferior alveolar nerve, and maxillary/mandibular bone to the planning software. YomiPlan software was upgraded from v2.4.1 to v2.7. Minor improvements include dual arch planning, restorative planning features, patient work volume guidance, YomiLink Bone planning enhancements, and control software optimizations. Hardware remains unchanged with no modifications to the robotic arm or patient tracking components.

Software verification and validation testing was performed per IEC 62304 Edition 1.1 2015 and FDA Guidance for Content of Premarket Submissions for Device Software Functions (June 2023). Cybersecurity testing followed FDA Guidance for Cybersecurity in Medical Devices (June 2025). Wireless coexistence testing per AAMI TIR69:2017 and IEEE ANSI C63.27-2017. Usability validation per FDA Guidance on Applying Human Factors and Usability Engineering to Medical Devices (February 2016).

The subject device has identical indications for use, intended user, use environment, and classification as the predicate (Yomi K231018). The automatic segmentation algorithm integration and minor software improvements do not change the fundamental technology or safety profile. Performance testing demonstrates substantially equivalent performance. All modifications have been verified and do not affect the overall safety and efficacy of the planning software.