FDA 510(k)

iCTmotor (WL-1)

K 號：K193341 · 2020-09-04

決定日期2020-09-04

產品代碼EBW

諮詢委員會DE

決定相當於

器材摘要

iCTmotor (WL-1) is the device name listed in this FDA 510(k) record. The listed applicant is Dentium Co., Ltd.. It received FDA 510(k) clearance on 2020-09-04 under 510(k) number K193341. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iCTmotor (WL-1)?

iCTmotor (WL-1) is a medical device that received FDA 510(k) clearance on 2020-09-04. The listed applicant is Dentium Co., Ltd.. The 510(k) number is K193341.

When did iCTmotor (WL-1) receive FDA 510(k) clearance?

iCTmotor (WL-1) received FDA 510(k) clearance on 2020-09-04, under 510(k) number K193341.

Who is the listed applicant for iCTmotor (WL-1)?

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

What is the FDA product code for iCTmotor (WL-1)?

The FDA product code for iCTmotor (WL-1) is EBW.

其他以 Dentium 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。

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相關器械（代碼：EBW）

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。

K251407電動手持式工具及控制單元（SDI10）Saeshin Precision Co., Ltd.K251701星 E900 電動系統Dentalez, Inc., Stardental Division K251811馬達與頂端模組（MaAM）Dentsply Sirona, Inc.K231562電機引擎（型號：ISE-170L）Micro-Nx Co., Ltd.K242646牙齒植體單位Guilin Aesthedent Medical Instruments Co., Ltd.K233288NLZ內置電機系統Nakanishi, Inc.

官方來源

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