FDA 510(k)

注射用根管封闭剂（KP-Root SP）

K号: K261415 · 2026-06-29

申请人Guilin Kevin Peter Technology Co., Ltd.

决定日期2026-06-29

产品代码KIF

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决定实质等同

器械摘要

Injectable Root Canal Sealer (KP-Root SP) is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Kevin Peter Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-06-29 under 510(k) number K261415. 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 Sealer (KP-Root SP)?

Injectable Root Canal Sealer (KP-Root SP) is a medical device that received FDA 510(k) clearance on 2026-06-29. The listed applicant is Guilin Kevin Peter Technology Co., Ltd.. The 510(k) number is K261415.

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

Injectable Root Canal Sealer (KP-Root SP) received FDA 510(k) clearance on 2026-06-29, under 510(k) number K261415.

Who is the listed applicant for Injectable Root Canal Sealer (KP-Root SP)?

FDA 510(k)记录将桂林科维特科技有限公司列为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Injectable Root Canal Sealer (KP-Root SP)?

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

列明Guilin Kevin Peter Technology 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。

K261047牙科二极管激光设备（激光笔）K261695流动修复材料（KP-Flow LF，KP-Flow MF，KP-Flow HF）K261514氢氧化钙临时填充材料（KP-Cal）

官方来源

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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。