Neocis Receives FDA Clearance for Yomi Bone Reduction Procedure

Manufacturer Neocis has received 510(k) clearance from the US Food and Drug Administration (FDA) for guided bone reduction for the company’s Yomi robot-assisted dental implant surgery system. It marks the company’s second FDA clearance this year and 14th to date.

This new indication will allow dental professionals to perform robot-guided alveoloplasty of the mandible and/or maxilla, helping them to take on complicated full-arch cases efficiently. A patient’s CT scan is used to digitally plan the bone reduction and placement of implants. During the procedure, Yomi’s guide arm provides haptic feedback to keep the burr from deviating beyond pre-planned boundaries. Unlike static guides, robot-assisted bone reduction allows clinicians to freely visualize, irrigate, and palpate the surgical site, as well as modify their treatment plan without sacrificing accuracy, according to a press release from Neocis.

“Not only does this allow implant clinicians to tackle full-arch restoration with a whole new level of accuracy and confidence, it pushes robot-assisted dental surgery into exciting new territory,” said Alon Mozes, Neocis co-founder and CEO. “This clearance is one of our most significant yet, as dental professionals can now use Yomi to perform truly volumetric 3D surgery.”

This combination of in-depth virtual planning and robotic guidance helps the user achieve a smooth, level ridge, which is critical to predictable and lasting restorative outcomes. Currently in the midst of a multi-site limited market release, Yomi’s bone reduction functionality is expected to be commercially available in early 2023.