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FDA 510(k)

NLZ Built-In Motor System

K-Number: K233288 · 2024-06-24

ApplicantNakanishi, Inc.
Decision Date2024-06-24
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NLZ Built-In Motor System is the device name listed in this FDA 510(k) record. The listed applicant is Nakanishi, Inc.. It received FDA 510(k) clearance on 2024-06-24 under 510(k) number K233288. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NLZ Built-In Motor System?

NLZ Built-In Motor System is a medical device that received FDA 510(k) clearance on 2024-06-24. The listed applicant is Nakanishi, Inc.. The 510(k) number is K233288.

When did NLZ Built-In Motor System receive FDA 510(k) clearance?

NLZ Built-In Motor System received FDA 510(k) clearance on 2024-06-24, under 510(k) number K233288.

Who is the listed applicant for NLZ Built-In Motor System?

The FDA 510(k) record lists Nakanishi, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NLZ Built-In Motor System?

The FDA product code for NLZ Built-In Motor System is EBW.

Other records listing Nakanishi, Inc. as applicant

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Related Devices (Code: EBW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251407Motor Handpiece and Control Unit (SDI10)Saeshin Precision Co., Ltd.K251701Star E900 Electric SystemDentalez, Inc., Stardental DivisionK251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc.K231562ELEC ENGINE (Model: ISE-170L)Micro-Nx Co., Ltd.K242646Dental Implant UnitGuilin Aesthedent Medical Instruments Co., Ltd.K233117Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)Nakanishi, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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