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FDA 510(k)

TopCEM陶瓷底漆陶瓷耦合劑

K 號：K242749 · 2024-11-08

申請人Rizhao Huge Biomaterials Company, Ltd.
決定日期2024-11-08
產品代碼KLE
諮詢委員會DE
決定相當於

器材摘要

TopCEM Ceramic Primer Ceramic Coupling Agent is the device name listed in this FDA 510(k) record. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. It received FDA 510(k) clearance on 2024-11-08 under 510(k) number K242749. 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 TopCEM Ceramic Primer Ceramic Coupling Agent?

TopCEM Ceramic Primer Ceramic Coupling Agent is a medical device that received FDA 510(k) clearance on 2024-11-08. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K242749.

When did TopCEM Ceramic Primer Ceramic Coupling Agent receive FDA 510(k) clearance?

TopCEM Ceramic Primer Ceramic Coupling Agent received FDA 510(k) clearance on 2024-11-08, under 510(k) number K242749.

Who is the listed applicant for TopCEM Ceramic Primer Ceramic Coupling Agent?

The FDA 510(k) record lists Rizhao Huge Biomaterials Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TopCEM Ceramic Primer Ceramic Coupling Agent?

The FDA product code for TopCEM Ceramic Primer Ceramic Coupling Agent is KLE.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Rizhao Huge Biomaterials Company, 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。

K252785TopCEM Vigor SA 自粘性樹脂水泥K251271TempFIT 暫時冠橋膠K242530HF-鹵化氫酸蝕刻膠K242572TopCEM-Try 薄層試戴膠K241204TopCEM-貼面光固化貼面水泥K233082TopCEM雙固化膠粘劑

查看所有 13 項裝置 →

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, LLCK260485Any-EtchMediclus Co., Ltd.K260430瓷刻膠Belport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ 過敏性膠粘劑Premier Dental Products CompanyK251587VITA VMLC 基質Vita Zahnfabrik H. Rauter GmbH & Co. Kg.

官方來源

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