Cleared Traditional

Varios Combi Pro2

K260773 · Nakanishi, Inc. · Dental
Mar 2026
Decision
1d
Days
Class 2
Risk

About This 510(k) Submission

K260773 is an FDA 510(k) clearance for the Varios Combi Pro2, a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by Nakanishi, Inc. (Kanuma, JP). The FDA issued a Cleared decision on March 10, 2026, 1 days after receiving the submission on March 9, 2026. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.

Submission Details

510(k) Number K260773 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2026
Decision Date March 10, 2026
Days to Decision 1 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELC — Scaler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4850

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