FDA 510(k)

PROXEO Twist 電動磨光系統 PL-40 H

K 號：K201703 · 2021-02-24

決定日期2021-02-24

產品代碼EKX

諮詢委員會DE

決定相當於

器材摘要

PROXEO Twist Cordless Polishing System PL-40 H is the device name listed in this FDA 510(k) record. The listed applicant is W&H Dentalwerk Buermoos GmbH. It received FDA 510(k) clearance on 2021-02-24 under 510(k) number K201703. 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 PROXEO Twist Cordless Polishing System PL-40 H?

PROXEO Twist Cordless Polishing System PL-40 H is a medical device that received FDA 510(k) clearance on 2021-02-24. The listed applicant is W&H Dentalwerk Buermoos GmbH. The 510(k) number is K201703.

When did PROXEO Twist Cordless Polishing System PL-40 H receive FDA 510(k) clearance?

PROXEO Twist Cordless Polishing System PL-40 H received FDA 510(k) clearance on 2021-02-24, under 510(k) number K201703.

Who is the listed applicant for PROXEO Twist Cordless Polishing System PL-40 H?

The FDA 510(k) record lists W&H Dentalwerk Buermoos GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROXEO Twist Cordless Polishing System PL-40 H?

The FDA product code for PROXEO Twist Cordless Polishing System PL-40 H is EKX.

其他以 W&H Dentalwerk Buermoos GmbH 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。

K253776植入式醫療設備 Plus II 及 Piezomed Plus II 模組 K243280Piezomed Pro (Piezomed Pro 模組 M-PM100 擴含手柄 M-PH350，Piezomed Pro 器材（各種尖端）及附件）K181858電動手持式機械頭電機 K171553W&H 協助儀雙用

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 AB K252223Alpha 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。