FDA 510(k)

JDentalCare植牙系統 JDIcon

K 號：K182081 · 2020-06-26

決定日期2020-06-26

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

JDentalCare Implant System JDIcon is the device name listed in this FDA 510(k) record. The listed applicant is Jdentalcare Srl. It received FDA 510(k) clearance on 2020-06-26 under 510(k) number K182081. 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 JDentalCare Implant System JDIcon?

JDentalCare Implant System JDIcon is a medical device that received FDA 510(k) clearance on 2020-06-26. The listed applicant is Jdentalcare Srl. The 510(k) number is K182081.

When did JDentalCare Implant System JDIcon receive FDA 510(k) clearance?

JDentalCare Implant System JDIcon received FDA 510(k) clearance on 2020-06-26, under 510(k) number K182081.

Who is the listed applicant for JDentalCare Implant System JDIcon?

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

What is the FDA product code for JDentalCare Implant System JDIcon?

The FDA product code for JDentalCare Implant System JDIcon is DZE.

其他以 Jdentalcare Srl 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。

K251148JDEvolution Plus L 和 JDEvolution Plus LE K240143JDD牙齦顎植體 K233896JDentalCare 牙齒植體系統：JDEvolution；JDEvolution plus；JDIcon；JDIcon plus

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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