# K222750 (us_fda)

FDA 510(k) K222750 for Neocis Yomi Robotic System. First and only FDA-cleared robot-assisted dental surgery system. Multiple subsequent clearances for full-arch, bone reduction, CT compatibility.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_510k
- Status: cleared
- Filing number: K222750
- Filing date: 2022-12-01
- Decision date: 2023-01-01
- Verification posture: verified
- Cap-flag notes: First and only FDA-cleared dental surgery robot.

## Applicant

- [Neocis](/companies/neocis.md)

## Covered models (2)

- [Yomi S](/models/neocis-yomi.md)
- [Yomi S](/models/yomi-s.md)

## Sources (1)

- [https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222750](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222750)

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