Cleared Traditional

NLZ Motor System

K163402 · Nakanishi, Inc. · Dental
Aug 2017
Decision
269d
Days
Class 1
Risk

About This 510(k) Submission

K163402 is an FDA 510(k) clearance for the NLZ Motor System, a Controller, Foot, Handpiece And Cord (Class I — General Controls, product code EBW), submitted by Nakanishi, Inc. (Kanuma, JP). The FDA issued a Cleared decision on August 31, 2017, 269 days after receiving the submission on December 5, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K163402 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2016
Decision Date August 31, 2017
Days to Decision 269 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBW — Controller, Foot, Handpiece And Cord
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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