FDA 510(k)

可注射根管生物陶瓷封闭剂 (i-MTA SP)

K号: K241977 · 2024-10-03

申请人Longly Biotechnology (Wuhan) Co., Ltd.

决定日期2024-10-03

产品代码KIF

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决定实质等同

器械摘要

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.

常见问题

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.

列明Longly Biotechnology (Wuhan) Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K242934生物陶瓷根管封闭剂和修复材料（i-MTA BP）

官方来源

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