FDA 510(k)

MIS V3 圆錐連接牙植體系統

K 號：K163349 · 2017-05-26

決定日期2017-05-26

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

MIS V3 Conical Connection Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Mis Implants Technologies , Ltd.. It received FDA 510(k) clearance on 2017-05-26 under 510(k) number K163349. 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 MIS V3 Conical Connection Dental Implant System?

MIS V3 Conical Connection Dental Implant System is a medical device that received FDA 510(k) clearance on 2017-05-26. The listed applicant is Mis Implants Technologies , Ltd.. The 510(k) number is K163349.

When did MIS V3 Conical Connection Dental Implant System receive FDA 510(k) clearance?

MIS V3 Conical Connection Dental Implant System received FDA 510(k) clearance on 2017-05-26, under 510(k) number K163349.

Who is the listed applicant for MIS V3 Conical Connection Dental Implant System?

The FDA 510(k) record lists Mis Implants Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIS V3 Conical Connection Dental Implant System?

The FDA product code for MIS V3 Conical Connection Dental Implant System is DZE.

其他以 Mis Implants Technologies , Ltd. 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。

K182228MIS LOCKiT 牙槽體系統，OT-等位線和球體連接件 K180282MIS內部六角牙植體系統 K173326MIS CONNECT 圆錐連接基座 K172505MIS C1 窄平台錐形連接植入系統，MIS C1 寬平台錐形連接基座

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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