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FDA 510(k)

Dental Handpiece, Wireless Endodontic Handpiece, endoit

K-Number: K232810 · 2023-11-09

ApplicantMicro-Nx Co., Ltd.
Decision Date2023-11-09
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Handpiece, Wireless Endodontic Handpiece, endoit is a medical device manufactured by Micro-Nx Co., Ltd.. It received FDA 510(k) clearance on 2023-11-09 under approval number K232810. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental Handpiece, Wireless Endodontic Handpiece, endoit?

Dental Handpiece, Wireless Endodontic Handpiece, endoit is a medical device that received FDA 510(k) clearance on 2023-11-09. It is manufactured by Micro-Nx Co., Ltd.. The 510(k) number is K232810.

When was Dental Handpiece, Wireless Endodontic Handpiece, endoit approved by the FDA?

Dental Handpiece, Wireless Endodontic Handpiece, endoit received FDA 510(k) clearance on 2023-11-09, under approval number K232810.

What company makes Dental Handpiece, Wireless Endodontic Handpiece, endoit?

Dental Handpiece, Wireless Endodontic Handpiece, endoit is manufactured by Micro-Nx Co., Ltd..

What is the FDA product code for Dental Handpiece, Wireless Endodontic Handpiece, endoit?

The FDA product code for Dental Handpiece, Wireless Endodontic Handpiece, endoit is EKX.

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Other Devices by Micro-Nx Co., Ltd.

K161500MEG-TORQ K192809Dental Handpiece K201192Impla-NX (Model: ISE-270M) K220577Dental Handpiece, Model CA160, CA160L, and CA500L K201191ELEC-LED K231562ELEC ENGINE (Model: ISE-170L)

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Related Devices (Code: EKX)

K160825MIDWEST RDH Freedom Cordless Prophy System with SmartMode TechnologyDentsply Sirona K153285EMS-200Meta Systems Co., Ltd. K143445Tellos ISQ BuddyTellos Medical AB K170275Tri Auto ZX2J. Morita USA, Inc. K161500MEG-TORQMicro-Nx Co., Ltd. K173920LS OILJ. Morita USA, 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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