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FDA 510(k)

立即載入式牙植體系統

K 號：K151757 · 2016-08-03

申請人Immediateload S.A.
決定日期2016-08-03
產品代碼DZE
諮詢委員會DE
決定相當於

器材摘要

IMMEDIATELOAD Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Immediateload S.A.. It received FDA 510(k) clearance on 2016-08-03 under 510(k) number K151757. 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 IMMEDIATELOAD Dental Implant System?

IMMEDIATELOAD Dental Implant System is a medical device that received FDA 510(k) clearance on 2016-08-03. The listed applicant is Immediateload S.A.. The 510(k) number is K151757.

When did IMMEDIATELOAD Dental Implant System receive FDA 510(k) clearance?

IMMEDIATELOAD Dental Implant System received FDA 510(k) clearance on 2016-08-03, under 510(k) number K151757.

Who is the listed applicant for IMMEDIATELOAD Dental Implant System?

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

What is the FDA product code for IMMEDIATELOAD Dental Implant System?

The FDA product code for IMMEDIATELOAD Dental Implant System is DZE.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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., LLCK260463ZEROS 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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