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FDA 510(k)

生物陶瓷根管封堵劑及修復材質（i-MTA BP）

K 號：K242934 · 2024-12-12

申請人Longly Biotechnology (Wuhan) Co., Ltd.
決定日期2024-12-12
產品代碼KIF
諮詢委員會DE
決定相當於

器材摘要

Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) is the device name listed in this FDA 510(k) record. The listed applicant is Longly Biotechnology (Wuhan) Co., Ltd.. It received FDA 510(k) clearance on 2024-12-12 under 510(k) number K242934. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)?

Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) is a medical device that received FDA 510(k) clearance on 2024-12-12. The listed applicant is Longly Biotechnology (Wuhan) Co., Ltd.. The 510(k) number is K242934.

When did Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) receive FDA 510(k) clearance?

Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) received FDA 510(k) clearance on 2024-12-12, under 510(k) number K242934.

Who is the listed applicant for Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)?

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

What is the FDA product code for Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)?

The FDA product code for Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) is KIF.

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 Longly Biotechnology (Wuhan) 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。

K241977注射式根管生物陶瓷封堵劑（i-MTA SP）

相關器械（代碼：KIF）

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。

K262050Vioseal XSpident Co., Ltd.K253909NeoPEX™ 預混充填膠NuSmile, Ltd.K261514鈣氫氧化臨時填充材質（KP-Cal）Guilin Kevin Peter Technology Co., Ltd.K261415注射式根管封閉劑（KP-Root SP）Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr Corporation

官方來源

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