Cleared Traditional

K062731 - ULTRASONIC SCALER

K062731 is the FDA 510(k) clearance for ULTRASONIC SCALER by Nakanishi, Inc.. It is a Class 2 Dental device (product code ELC) cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K062731 · Nakanishi, Inc. · Dental device
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May 2007
Decision
230d
Days
Class 2
Risk

K062731 is an FDA 510(k) clearance for the ULTRASONIC SCALER, VARIOS 560. 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 May 1, 2007 after a review of 230 days - an extended review cycle.

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 K062731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2006
Decision Date May 01, 2007
Days to Decision 230 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
103d slower than avg
Panel avg: 127d · This submission: 230d
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 K062731.
VARIOS 75
K071447 · Nakanishi, Inc. · Apr 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
J. MORITA AZ ULTRASONIC SYSTEM
K053030 · J. Morita USA, Inc. · Nov 2005
CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131
K052334 · Dentsply Intl. · Sep 2005
PERIOSCAN ULTRASONIC SCALER
K050354 · Sirona Dental Systems GmbH · Mar 2005