FDA 510(k)

INNO SLA Mini Plus® 假體系統

K 號：K241127 · 2024-12-27

決定日期2024-12-27

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

INNO SLA Mini Plus® Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Cowellmedi Co., Ltd.. It received FDA 510(k) clearance on 2024-12-27 under 510(k) number K241127. 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 INNO SLA Mini Plus® Implant System?

INNO SLA Mini Plus® Implant System is a medical device that received FDA 510(k) clearance on 2024-12-27. The listed applicant is Cowellmedi Co., Ltd.. The 510(k) number is K241127.

When did INNO SLA Mini Plus® Implant System receive FDA 510(k) clearance?

INNO SLA Mini Plus® Implant System received FDA 510(k) clearance on 2024-12-27, under 510(k) number K241127.

Who is the listed applicant for INNO SLA Mini Plus® Implant System?

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

What is the FDA product code for INNO SLA Mini Plus® Implant System?

The FDA product code for INNO SLA Mini Plus® Implant System is DZE.

其他以 Cowellmedi Co., Ltd. 為申請人之記錄

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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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