Cleared Traditional

K071447 - VARIOS 75

K071447 is the FDA 510(k) clearance for VARIOS 75 by Nakanishi, Inc.. It is a Class 2 Dental device (product code ELC) cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K071447 · Nakanishi, Inc. · Dental device
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Apr 2008
Decision
330d
Days
Class 2
Risk

K071447 is an FDA 510(k) clearance for the VARIOS 75. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Nakanishi, Inc. (Kanuma-Shi, JP). The FDA issued a Cleared decision on April 18, 2008 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K071447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2007
Decision Date April 18, 2008
Days to Decision 330 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
203d slower than avg
Panel avg: 127d · This submission: 330d
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 56
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K071447.
ULTRASONIC SCALER
K113530 · Nakanishi, Inc. · Jan 2013
A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
K100647 · A-Dec, Inc. · Jul 2010
SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS
K080089 · Sybron Dental Specialties, Inc. · Sep 2008
PERIOSCAN, MODEL: D 3496
K072107 · Sirona Dental Systems GmbH · Feb 2008
STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT
K070307 · Dentsply International, Inc. · May 2007
ULTRASONIC SCALER, VARIOS 560
K062731 · Nakanishi, Inc. · May 2007