Cleared Traditional

K251689 - VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10) (FDA 510(k) Clearance)

Also includes:
VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11) VARIOS 170 SCALER SYSTEM (VA170S11)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251689 · Nakanishi, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
109d
Days
Class 2
Risk

K251689 is an FDA 510(k) clearance for the VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10). Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Nakanishi, Inc. (Kanuma, JP). The FDA issued a Cleared decision on September 19, 2025 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Nakanishi, Inc. devices

Submission Details

510(k) Number K251689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 127d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELC Scaler, Ultrasonic

All 194
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K251689.
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