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FDA 510(k)

ELEC ENGINE (Model: ISE-170L)

K-Number: K231562 · 2025-07-18

ApplicantMicro-Nx Co., Ltd.
Decision Date2025-07-18
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ELEC ENGINE (Model: ISE-170L) is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Nx Co., Ltd.. It received FDA 510(k) clearance on 2025-07-18 under 510(k) number K231562. 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 ENGINE (Model: ISE-170L)?

ELEC ENGINE (Model: ISE-170L) is a medical device that received FDA 510(k) clearance on 2025-07-18. The listed applicant is Micro-Nx Co., Ltd.. The 510(k) number is K231562.

When did ELEC ENGINE (Model: ISE-170L) receive FDA 510(k) clearance?

ELEC ENGINE (Model: ISE-170L) received FDA 510(k) clearance on 2025-07-18, under 510(k) number K231562.

Who is the listed applicant for ELEC ENGINE (Model: ISE-170L)?

The FDA 510(k) record lists Micro-Nx Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELEC ENGINE (Model: ISE-170L)?

The FDA product code for ELEC ENGINE (Model: ISE-170L) is EBW.

Other records listing Micro-Nx Co., Ltd. as applicant

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.

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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.K242646Dental Implant UnitGuilin Aesthedent Medical Instruments Co., Ltd.K233288NLZ Built-In Motor SystemNakanishi, Inc.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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