Regulatory filing

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.

fda 510k · cleared · decided 2023-01-01

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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

Covered models (2)

Sources (1)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222750

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Identity

2f99aed1-d4f5-4794-a6be-ff8884421c8e