Cleared Traditional

VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)

K251689 · Nakanishi, Inc. · Dental
Sep 2025
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K251689 is an FDA 510(k) clearance for the VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11), a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by Nakanishi, Inc. (Kanuma, JP). The FDA issued a Cleared decision on September 19, 2025, 109 days after receiving the submission on June 2, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.

Submission Details

510(k) Number K251689 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2025
Decision Date September 19, 2025
Days to Decision 109 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

Similar Devices — ELC Scaler, Ultrasonic

All 194
Varios Combi Pro2
K260773 · Nakanishi, Inc. · Mar 2026
GBT Machine Airflow Prophylaxis Master
K253254 · E.M.S Electro Medical Systems S.A · Jan 2026
Integrated Endo System (Meet Endo-II)
K242317 · Denjoy Dental Co., Ltd. · Feb 2025
OdneClean
K233844 · Odne AG · Aug 2024
Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)
K240707 · Shenzhen Micro Electric Intelligence Co., Ltd. · Jul 2024
BioSonic US200 Ultrasonic Scaler (60034537)
K240801 · Dent4you AG · Jul 2024