Cleared Traditional

Dental Handpiece, Wireless Endodontic Handpiece, endoit

K232810 · Micro-Nx Co., Ltd. · Dental
Nov 2023
Decision
58d
Days
Class 1
Risk

About This 510(k) Submission

K232810 is an FDA 510(k) clearance for the Dental Handpiece, Wireless Endodontic Handpiece, endoit, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Micro-Nx Co., Ltd. (Dong-Gu, KR). The FDA issued a Cleared decision on November 9, 2023, 58 days after receiving the submission on September 12, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K232810 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2023
Decision Date November 09, 2023
Days to Decision 58 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EKX — Handpiece, Direct Drive, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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