FDA 510(k)

Noris Medical MBI 齒齒植入系統

K 號：K153043 · 2016-04-11

決定日期2016-04-11

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

Noris Medical MBI 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 2016-04-11 under 510(k) number K153043. 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 Dental Implant System?

Noris Medical MBI Dental Implant System is a medical device that received FDA 510(k) clearance on 2016-04-11. The listed applicant is Noris Medical , Ltd.. The 510(k) number is K153043.

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

Noris Medical MBI Dental Implant System received FDA 510(k) clearance on 2016-04-11, under 510(k) number K153043.

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

The FDA product code for Noris Medical MBI 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 K162308諾里斯醫療 MBI-2mm 牙齒植體系統 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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