免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

牙科手持機，無線根管手持機，endoit

K 號：K232810 · 2023-11-09

申請人Micro-Nx Co., Ltd.
決定日期2023-11-09
產品代碼EKX
諮詢委員會DE
決定相當於

器材摘要

Dental Handpiece, Wireless Endodontic Handpiece, endoit 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 2023-11-09 under 510(k) number K232810. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

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. The listed applicant is Micro-Nx Co., Ltd.. The 510(k) number is K232810.

When did Dental Handpiece, Wireless Endodontic Handpiece, endoit receive FDA 510(k) clearance?

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

Who is the listed applicant for Dental Handpiece, Wireless Endodontic Handpiece, endoit?

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 Dental Handpiece, Wireless Endodontic Handpiece, endoit?

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

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Micro-Nx Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K231562電機引擎（型號：ISE-170L）K220577牙科手持機，型號CA160、CA160L及CA500LK201191電子LEDK201192Impla-NX（型號：ISE-270M）K192809牙科手持工具K161500MEG-TORQ

查看所有 7 項裝置 →

相關器械（代碼：EKX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261987可重用智慧釘Osstell ABK252223Alpha Endo 手柄（Alpha Endo）SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597內視系統Perimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo 電機 (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑