FDA 510(k)

G-Bond 選擇性

K 號：K251124 · 2025-10-02

決定日期2025-10-02

產品代碼KLE

諮詢委員會DE

決定相當於

器材摘要

G-Bond Universal is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 2025-10-02 under 510(k) number K251124. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the G-Bond Universal?

G-Bond Universal is a medical device that received FDA 510(k) clearance on 2025-10-02. The listed applicant is GC America, Inc.. The 510(k) number is K251124.

When did G-Bond Universal receive FDA 510(k) clearance?

G-Bond Universal received FDA 510(k) clearance on 2025-10-02, under 510(k) number K251124.

Who is the listed applicant for G-Bond Universal?

FDA 510(k) 記錄將 GC America, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for G-Bond Universal?

The FDA product code for G-Bond Universal is KLE.

其他以 GC America, Inc. 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。

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相關器械（代碼：KLE）

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。

K262252MPa 最大膠粘劑Den-Mat Holdings, LLC K260485Any-EtchMediclus Co., Ltd.K260430瓷刻膠Belport Company, Inc., Gingi-Pak K252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ 過敏性膠粘劑Premier Dental Products Company K251587VITA VMLC 基質Vita Zahnfabrik H. Rauter GmbH & Co. Kg.

官方來源

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