FDA 510(k)

牙齒植體OKTAGON組織層級與骨層級

K 號：K162073 · 2017-02-24

決定日期2017-02-24

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

Dental Implants OKTAGON Tissue Level and Bone Level is the device name listed in this FDA 510(k) record. The listed applicant is Hager& Meisinger GmbH. It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K162073. 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 Dental Implants OKTAGON Tissue Level and Bone Level?

Dental Implants OKTAGON Tissue Level and Bone Level is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Hager& Meisinger GmbH. The 510(k) number is K162073.

When did Dental Implants OKTAGON Tissue Level and Bone Level receive FDA 510(k) clearance?

Dental Implants OKTAGON Tissue Level and Bone Level received FDA 510(k) clearance on 2017-02-24, under 510(k) number K162073.

Who is the listed applicant for Dental Implants OKTAGON Tissue Level and Bone Level?

The FDA 510(k) record lists Hager& Meisinger GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Implants OKTAGON Tissue Level and Bone Level?

The FDA product code for Dental Implants OKTAGON Tissue Level and Bone Level is DZE.

其他以 Hager& Meisinger GmbH 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。

K250123Master-Pin X (帶絲牙的MP釘針) (36BMP000030 / MP30)K240321MP 平面釘無絲 (36BMP000020/MP20)K201210微螺釘系統，微螺釘系統基本版 K173819MyPlant II 偽裝系統 K180360OKTAGON 嵌入系統 K170287牙齒植體 OKTAGON 骨水平針狹設計

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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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