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FDA 510(k)

ELEC-LED

K-Number: K201191 · 2022-02-07

ApplicantMicro-Nx Co., Ltd.
Decision Date2022-02-07
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ELEC-LED is a medical device manufactured by Micro-Nx Co., Ltd.. It received FDA 510(k) clearance on 2022-02-07 under approval number K201191. 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 ELEC-LED?

ELEC-LED is a medical device that received FDA 510(k) clearance on 2022-02-07. It is manufactured by Micro-Nx Co., Ltd.. The 510(k) number is K201191.

When was ELEC-LED approved by the FDA?

ELEC-LED received FDA 510(k) clearance on 2022-02-07, under approval number K201191.

What company makes ELEC-LED?

ELEC-LED is manufactured by Micro-Nx Co., Ltd..

What is the FDA product code for ELEC-LED?

The FDA product code for ELEC-LED is EBW.

Other Devices by Micro-Nx Co., Ltd.

K161500MEG-TORQ K192809Dental Handpiece K201192Impla-NX (Model: ISE-270M) K220577Dental Handpiece, Model CA160, CA160L, and CA500L K232810Dental Handpiece, Wireless Endodontic Handpiece, endoit K231562ELEC ENGINE (Model: ISE-170L)

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Related Devices (Code: EBW)

K161957W&H Implantmed SI-1015 incl. AccessoriesW&H Dentalwerk Burmoos GmbH K163402NLZ Motor SystemNakanishi, Inc. K163131A-dec NLZ Electric Motor SystemNakanishi, Inc. K163317ELECTROmaticKaltenbach & Voigt Gmgh K161213XSmart iQDentsply Sirona K173905Surgic Pro, Surgic Pro+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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