FDA 510(k)

諾里斯醫療 MBI-2mm 牙齒植體系統

K 號：K162308 · 2017-03-17

決定日期2017-03-17

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

Noris Medical MBI-2mm Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Noris Medical , Ltd.. It received FDA 510(k) clearance on 2017-03-17 under 510(k) number K162308. 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 Noris Medical MBI-2mm Dental Implant System?

Noris Medical MBI-2mm Dental Implant System is a medical device that received FDA 510(k) clearance on 2017-03-17. The listed applicant is Noris Medical , Ltd.. The 510(k) number is K162308.

When did Noris Medical MBI-2mm Dental Implant System receive FDA 510(k) clearance?

Noris Medical MBI-2mm Dental Implant System received FDA 510(k) clearance on 2017-03-17, under 510(k) number K162308.

Who is the listed applicant for Noris Medical MBI-2mm Dental Implant System?

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

What is the FDA product code for Noris Medical MBI-2mm Dental Implant System?

The FDA product code for Noris Medical MBI-2mm Dental Implant System is DZE.

其他以 Noris Medical , 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。

K241462長頸鹿植入體及長頸鹿-N植入體 K240202錐形平台牙植體系統 K210852諾里斯醫療牙植體系統 - 外板 K210356諾里斯醫療牙植體系統 K153043Noris Medical MBI 齒齒植入系統 K151909諾里斯醫療顯顎牙植體系統

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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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