FDA 510(k)

JDD牙齦顎植體

K 號：K240143 · 2024-10-11

決定日期2024-10-11

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

JDZygoma dental implants is the device name listed in this FDA 510(k) record. The listed applicant is Jdentalcare Srl. It received FDA 510(k) clearance on 2024-10-11 under 510(k) number K240143. 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 JDZygoma dental implants?

JDZygoma dental implants is a medical device that received FDA 510(k) clearance on 2024-10-11. The listed applicant is Jdentalcare Srl. The 510(k) number is K240143.

When did JDZygoma dental implants receive FDA 510(k) clearance?

JDZygoma dental implants received FDA 510(k) clearance on 2024-10-11, under 510(k) number K240143.

Who is the listed applicant for JDZygoma dental implants?

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 JDZygoma dental implants?

The FDA product code for JDZygoma dental implants 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 K233896JDentalCare 牙齒植體系統：JDEvolution；JDEvolution plus；JDIcon；JDIcon plus K182081JDentalCare植牙系統 JDIcon

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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