FDA 510(k)

NizPlant 齿科植體系統

K 號：K250476 · 2025-12-23

決定日期2025-12-23

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

NizPlant Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Paragon Implant Mfg., LLC. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K250476. 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 NizPlant Dental Implant System?

NizPlant Dental Implant System is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Paragon Implant Mfg., LLC. The 510(k) number is K250476.

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

NizPlant Dental Implant System received FDA 510(k) clearance on 2025-12-23, under 510(k) number K250476.

Who is the listed applicant for NizPlant Dental Implant System?

FDA 510(k) 記錄將 Paragon Implant Mfg., LLC 列為申請人。這並不單獨確立設備製造商。

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

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

其他以 Paragon Implant Mfg., LLC 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。

K261392三活牙植體系統 K252145GEN5™ 及 GEN5+™ 3.3mmD 齒齒植體 K251756消毒盤 K251938GEN5及GEN5+ 齿植系統

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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