FDA 510(k)

BTI Interna 窄/加大號牙齒植體系統 UnicCa

K 號：K211952 · 2022-07-21

決定日期2022-07-21

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

BTI Interna Narrow/Plus 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 2022-07-21 under 510(k) number K211952. 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 Interna Narrow/Plus Dental Implant System UnicCa?

BTI Interna Narrow/Plus Dental Implant System UnicCa is a medical device that received FDA 510(k) clearance on 2022-07-21. The listed applicant is B.T.I. Biotechnology Institute, Sl.. The 510(k) number is K211952.

When did BTI Interna Narrow/Plus Dental Implant System UnicCa receive FDA 510(k) clearance?

BTI Interna Narrow/Plus Dental Implant System UnicCa received FDA 510(k) clearance on 2022-07-21, under 510(k) number K211952.

Who is the listed applicant for BTI Interna Narrow/Plus 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 Interna Narrow/Plus Dental Implant System UnicCa?

The FDA product code for BTI Interna Narrow/Plus 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。

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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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