K251835
- 510(k) number
- K251835
- Device name
- Yomi Robotic System
- Applicant
- Neocis, Inc. FL · US
- Product code
- PLV — Dental Stereotaxic Instrument
- Decision date
- 2025-10-10
- Date received
- 2025-06-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251835.pdf
Official FDA record: K251835
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.