可注射根管生物陶瓷封闭剂 (nRoot SP)
K号: K250710 · 2025-06-11
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决定日期2025-06-11
产品代码KIF
咨询委员会DE
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器械摘要
Injectable Root Canal Bioceramic Sealer (nRoot SP) is the device name listed in this FDA 510(k) record. The listed applicant is Enpuno Co., Ltd.. It received FDA 510(k) clearance on 2025-06-11 under 510(k) number K250710. 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 (nRoot SP)?
Injectable Root Canal Bioceramic Sealer (nRoot SP) is a medical device that received FDA 510(k) clearance on 2025-06-11. The listed applicant is Enpuno Co., Ltd.. The 510(k) number is K250710.
When did Injectable Root Canal Bioceramic Sealer (nRoot SP) receive FDA 510(k) clearance?
Injectable Root Canal Bioceramic Sealer (nRoot SP) received FDA 510(k) clearance on 2025-06-11, under 510(k) number K250710.
Who is the listed applicant for Injectable Root Canal Bioceramic Sealer (nRoot SP)?
The FDA 510(k) record lists Enpuno 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 (nRoot SP)?
The FDA product code for Injectable Root Canal Bioceramic Sealer (nRoot SP) is KIF.
相关临床试验
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相关器械（代码：KIF）
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。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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