FDA 510(k)

SIC發明牙植體系統

K 號：K173207 · 2018-04-05

決定日期2018-04-05

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

SIC invent Dental Implant Systems is the device name listed in this FDA 510(k) record. The listed applicant is Sic Invent AG. It received FDA 510(k) clearance on 2018-04-05 under 510(k) number K173207. 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 SIC invent Dental Implant Systems?

SIC invent Dental Implant Systems is a medical device that received FDA 510(k) clearance on 2018-04-05. The listed applicant is Sic Invent AG. The 510(k) number is K173207.

When did SIC invent Dental Implant Systems receive FDA 510(k) clearance?

SIC invent Dental Implant Systems received FDA 510(k) clearance on 2018-04-05, under 510(k) number K173207.

Who is the listed applicant for SIC invent Dental Implant Systems?

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

What is the FDA product code for SIC invent Dental Implant Systems?

The FDA product code for SIC invent Dental Implant Systems is DZE.

其他以 Sic Invent 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。

K252904SIC 牙槽橋，包括 CAD/CAM 解決方案 K210489SIC收縮型 & SICvantage收縮型

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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