FDA 510(k)

BTI 齿科植體系統 UnicCa

K 號：K151391 · 2016-05-02

決定日期2016-05-02

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

BTI Dental Implant System UnicCa is the device name listed in this FDA 510(k) record. The listed applicant is B.T.I. Biotechnology Institute, Sl.. It received FDA 510(k) clearance on 2016-05-02 under 510(k) number K151391. 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 BTI Dental Implant System UnicCa?

BTI Dental Implant System UnicCa is a medical device that received FDA 510(k) clearance on 2016-05-02. The listed applicant is B.T.I. Biotechnology Institute, Sl.. The 510(k) number is K151391.

When did BTI Dental Implant System UnicCa receive FDA 510(k) clearance?

BTI Dental Implant System UnicCa received FDA 510(k) clearance on 2016-05-02, under 510(k) number K151391.

Who is the listed applicant for BTI Dental Implant System UnicCa?

The FDA 510(k) record lists B.T.I. Biotechnology Institute, Sl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BTI Dental Implant System UnicCa?

The FDA product code for BTI Dental Implant System UnicCa is DZE.

其他以 B.T.I. Biotechnology Institute, Sl. 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。

K240262BTI Interna 3.0 齿植系統 UnicCa®K232750BTI Interna 假肢零件 K231827BTI 牙齒植體系統 UnicCa® – 美學後牙臥臥臼 K213106BTI Interna 齒齒植體系統 UnicCa - 假牙零件 K211952BTI Interna 窄/加大號牙齒植體系統 UnicCa K202825BTI超短牙植體系統UnicCa

查看所有 8 項裝置 →

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

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。