FDA 510(k)

托姆恩植入系統

K 號：K171795 · 2017-09-29

決定日期2017-09-29

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

Thommen Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Thommen Medical AG. It received FDA 510(k) clearance on 2017-09-29 under 510(k) number K171795. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Thommen Implant System?

Thommen Implant System is a medical device that received FDA 510(k) clearance on 2017-09-29. The listed applicant is Thommen Medical AG. The 510(k) number is K171795.

When did Thommen Implant System receive FDA 510(k) clearance?

Thommen Implant System received FDA 510(k) clearance on 2017-09-29, under 510(k) number K171795.

Who is the listed applicant for Thommen Implant System?

The FDA 510(k) record lists Thommen Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thommen Implant System?

The FDA product code for Thommen Implant System is DZE.

其他以 Thommen Medical AG 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。

K160244VARIOunite K151984Thommen 齒科基座用於 CAD/CAM

相關器械（代碼：DZE）

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。

K261392三活牙植體系統Paragon Implant Mfg., LLC K260463ZEROS 齿科植體系統Zeros Co., Ltd.K251188UNIQA® 齿科植體系統Uniqa Dental, Ltd.K251232MegaGen 遺傳子顎骨牙植體系統Megagen Implant Co., Ltd.K250806牙齒植體系統A.B. Dental Devices , Ltd.K260006INOS系統Inosys, Inc.

官方來源

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