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FDA 510(k)

Impla-NX (Model: ISE-270M)

K-Number: K201192 · 2021-05-21

ApplicantMicro-Nx Co., Ltd.
Decision Date2021-05-21
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Impla-NX (Model: ISE-270M) 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 2021-05-21 under 510(k) number K201192. 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 Impla-NX (Model: ISE-270M)?

Impla-NX (Model: ISE-270M) is a medical device that received FDA 510(k) clearance on 2021-05-21. The listed applicant is Micro-Nx Co., Ltd.. The 510(k) number is K201192.

When did Impla-NX (Model: ISE-270M) receive FDA 510(k) clearance?

Impla-NX (Model: ISE-270M) received FDA 510(k) clearance on 2021-05-21, under 510(k) number K201192.

Who is the listed applicant for Impla-NX (Model: ISE-270M)?

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 Impla-NX (Model: ISE-270M)?

The FDA product code for Impla-NX (Model: ISE-270M) 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.

K231562ELEC ENGINE (Model: ISE-170L)K232810Dental Handpiece, Wireless Endodontic Handpiece, endoitK220577Dental Handpiece, Model CA160, CA160L, and CA500LK201191ELEC-LEDK192809Dental HandpieceK161500MEG-TORQ

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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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