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FDA 510(k)

A-dec NLZ Electric Motor System

K-Number: K163131 · 2017-05-11

ApplicantNakanishi, Inc.
Decision Date2017-05-11
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

A-dec NLZ Electric 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 2017-05-11 under 510(k) number K163131. 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 A-dec NLZ Electric Motor System?

A-dec NLZ Electric Motor System is a medical device that received FDA 510(k) clearance on 2017-05-11. The listed applicant is Nakanishi, Inc.. The 510(k) number is K163131.

When did A-dec NLZ Electric Motor System receive FDA 510(k) clearance?

A-dec NLZ Electric Motor System received FDA 510(k) clearance on 2017-05-11, under 510(k) number K163131.

Who is the listed applicant for A-dec NLZ Electric 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 A-dec NLZ Electric Motor System?

The FDA product code for A-dec NLZ Electric 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.K233288NLZ Built-In Motor SystemNakanishi, 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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