{"id":"2f99aed1-d4f5-4794-a6be-ff8884421c8e","slug":"neocis-yomi-fda-510k-k222750","filingNumber":"K222750","filingType":"fda_510k","jurisdiction":"us_fda","applicantCompanyId":"6502bb45-7c3f-4e3b-ad1f-5c0fe1738696","filingDate":"2022-12-01T00:00:00.000Z","decisionDate":"2023-01-01T00:00:00.000Z","status":"cleared","clearanceScope":"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.","sources":[{"url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222750","title":"K222750 510(k)","sourceName":"FDA 510(k) Database"}],"verificationPosture":"verified","capFlagNotes":"First and only FDA-cleared dental surgery robot.","relatedIncidentId":null,"reviewStatus":"unreviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-07-15T02:28:28.655Z","updatedAt":"2026-07-15T02:28:28.655Z","applicantCompany":{"id":"6502bb45-7c3f-4e3b-ad1f-5c0fe1738696","slug":"neocis","name":"Neocis"},"modelLinks":[{"id":"3854793b-241a-451e-ae3c-a3b088778e78","modelId":"59ecd908-5790-40bc-b7f0-e27628adb473","regulatoryFilingId":"2f99aed1-d4f5-4794-a6be-ff8884421c8e","createdAt":"2026-07-15T02:28:29.526Z","model":{"slug":"neocis-yomi","modelName":"Yomi S"}},{"id":"9a82062e-ee3d-44ff-926a-da4d69e53584","modelId":"63feef63-412c-4520-93b6-8ffa1a826c6b","regulatoryFilingId":"2f99aed1-d4f5-4794-a6be-ff8884421c8e","createdAt":"2026-07-15T02:28:30.402Z","model":{"slug":"yomi-s","modelName":"Yomi S"}}]}