Cleared Traditional

ULTRASONIC SCALER

K113717 · Nakanishi, Inc. · Dental
Mar 2013
Decision
442d
Days
Class 2
Risk

About This 510(k) Submission

K113717 is an FDA 510(k) clearance for the ULTRASONIC SCALER, a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by Nakanishi, Inc. (Richardson, US). The FDA issued a Cleared decision on March 5, 2013, 442 days after receiving the submission on December 19, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.

Submission Details

510(k) Number K113717 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2011
Decision Date March 05, 2013
Days to Decision 442 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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