Cleared Traditional

A-dec NLZ Electric Motor System

K163131 · Nakanishi, Inc. · Dental
May 2017
Decision
184d
Days
Class 1
Risk

About This 510(k) Submission

K163131 is an FDA 510(k) clearance for the A-dec NLZ Electric 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 May 11, 2017, 184 days after receiving the submission on November 8, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K163131 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2016
Decision Date May 11, 2017
Days to Decision 184 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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