K254163
- 510(k) number
- K254163
- Device name
- VarioSurg 4
- Applicant
- Nakanishi, Inc. JP
- Product code
- DZI — Drill, Bone, Powered
- Decision date
- 2025-12-23
- Date received
- 2025-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K254163.pdf
Official FDA record: K254163
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.