Cleared Traditional

VarioSurg 4

K254163 · Nakanishi, Inc. · Dental
Dec 2025
Decision
1d
Days
Class 2
Risk

About This 510(k) Submission

K254163 is an FDA 510(k) clearance for the VarioSurg 4, 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 days after receiving the submission on December 22, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K254163 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code DZI — Drill, Bone, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120

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