FDA 510(k)

ZENEX 嵌入系統_短 (R-系統)

K 號：K253334 · 2026-03-16

決定日期2026-03-16

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

ZENEX Implant System_Short (R-System) is the device name listed in this FDA 510(k) record. The listed applicant is Izenimplant Co., Ltd.. It received FDA 510(k) clearance on 2026-03-16 under 510(k) number K253334. 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 ZENEX Implant System_Short (R-System)?

ZENEX Implant System_Short (R-System) is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is Izenimplant Co., Ltd.. The 510(k) number is K253334.

When did ZENEX Implant System_Short (R-System) receive FDA 510(k) clearance?

ZENEX Implant System_Short (R-System) received FDA 510(k) clearance on 2026-03-16, under 510(k) number K253334.

Who is the listed applicant for ZENEX Implant System_Short (R-System)?

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

What is the FDA product code for ZENEX Implant System_Short (R-System)?

The FDA product code for ZENEX Implant System_Short (R-System) is DZE.

其他以 Izenimplant Co., 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。

K252585ZENEX 嵌入系統_R-System K240560ZENEX 嵌入系統_長 K232170Ti Link 齿槽連接器 K233163ZENEX 嵌入系統_簡短 K231557ZENEX FreeMilling & CCM 銅結牙根座 K230630ZENEX 嵌入系統_窄版

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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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