Cleared Traditional

NLZ Built-In Motor System

K233288 · Nakanishi, Inc. · Dental
Jun 2024
Decision
269d
Days
Class 1
Risk

About This 510(k) Submission

K233288 is an FDA 510(k) clearance for the NLZ Built-In 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 June 24, 2024, 269 days after receiving the submission on September 29, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K233288 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2023
Decision Date June 24, 2024
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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