BACKGROUNDRegulatoryTier 1
FDA 510(k) K261321: Yomi S Robotic System
Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.
Why it matters for dental
Dental practices evaluating navigation-assisted implant systems gain a new Class II device option cleared through the FDA 510(k) pathway.
Key points
- Neocis, Inc. received 510(k) clearance K261321 for the Yomi S Robotic System as a dental navigation system.
- The device is classified as Class 2 under product code QRY and regulation 872.4120.
- The FDA cleared the system through the Traditional substantially equivalent pathway.
Who should care
OwnerSpecialist
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