Regulator
The FDA cleared Neocis's guidance system, later sold as Yomi, through the 510(k) route (K161399). Neocis says it was the first robot cleared for dental implant surgery.
A regulator's decision · Sets Yomi's stage
What the source says
“it won FDA 510(k) clearance for its Yomi robotic guidance system for dental implant procedures”
What it means
Yomi, from Neocis, is at stage 5 of 5 on our ladder: regulator-cleared or mass market. This event is one of the milestones that placed it there.
Human help: Our sources report it working without human help.
More on Yomi
- Neocis said clinicians had done more than 100,000 implant drillings with Yomi.
- The FDA cleared Yomi S, a next-generation version, through the 510(k) route (K252376). Neocis launched it in November 2025; one person can run it with a foot pedal and touchscreen.
- Neocis raised about $70 million in a round led by DFJ Growth.
- Neocis said more than 2,700 procedures had been done with Yomi in 50 US cities.
- Neocis began selling Yomi widely at the start of 2018.