FDA 510(k)

UF(II) 窄植系統 - 預置件，UF(II) 窄植系統 - 上架結構

K 號：K161987 · 2017-02-21

決定日期2017-02-21

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure is the device name listed in this FDA 510(k) record. The listed applicant is Dio Corporation. It received FDA 510(k) clearance on 2017-02-21 under 510(k) number K161987. 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 UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure?

UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure is a medical device that received FDA 510(k) clearance on 2017-02-21. The listed applicant is Dio Corporation. The 510(k) number is K161987.

When did UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure receive FDA 510(k) clearance?

UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure received FDA 510(k) clearance on 2017-02-21, under 510(k) number K161987.

Who is the listed applicant for UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure?

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

What is the FDA product code for UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure?

The FDA product code for UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure is DZE.

其他以 Dio Corporation 為申請人之記錄

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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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