K254163 is an FDA 510(k) clearance for the VarioSurg 4. This device is classified as a Drill, Bone, Powered (Class II - Special Controls, product code DZI).
Submitted by Nakanishi, Inc. (Kanuma, JP). The FDA issued a Cleared decision on December 23, 2025, 1 day after receiving the submission on December 22, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K254163 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2025 |
| Decision Date | December 23, 2025 |
| Days to Decision | 1 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZI — Drill, Bone, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4120 |