FDA 510(k)

注射式根管生物陶瓷封堵劑（i-MTA SP）

K 號：K241977 · 2024-10-03

申請人Longly Biotechnology (Wuhan) Co., Ltd.

決定日期2024-10-03

產品代碼KIF

諮詢委員會DE

決定相當於

器材摘要

Injectable Root Canal Bioceramic Sealer (i-MTA SP) 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 2024-10-03 under 510(k) number K241977. 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 Injectable Root Canal Bioceramic Sealer (i-MTA SP)?

Injectable Root Canal Bioceramic Sealer (i-MTA SP) is a medical device that received FDA 510(k) clearance on 2024-10-03. The listed applicant is Longly Biotechnology (Wuhan) Co., Ltd.. The 510(k) number is K241977.

When did Injectable Root Canal Bioceramic Sealer (i-MTA SP) receive FDA 510(k) clearance?

Injectable Root Canal Bioceramic Sealer (i-MTA SP) received FDA 510(k) clearance on 2024-10-03, under 510(k) number K241977.

Who is the listed applicant for Injectable Root Canal Bioceramic Sealer (i-MTA SP)?

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 Injectable Root Canal Bioceramic Sealer (i-MTA SP)?

The FDA product code for Injectable Root Canal Bioceramic Sealer (i-MTA SP) is KIF.

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。

K242934生物陶瓷根管封堵劑及修復材質（i-MTA BP）

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。

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官方來源

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