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FDA 510(k)

Signum 复合流；Signum 通用粘合剂；Signum 金属粘合剂；Signum 复合；Signum 矩阵；Signum 液体；Signum cre-active

K号: K240660 · 2024-09-17

申请人Kulzer, LLC
决定日期2024-09-17
产品代码EBF
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决定实质等同

器械摘要

Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, LLC. It received FDA 510(k) clearance on 2024-09-17 under 510(k) number K240660. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active?

Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active is a medical device that received FDA 510(k) clearance on 2024-09-17. The listed applicant is Kulzer, LLC. The 510(k) number is K240660.

When did Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active receive FDA 510(k) clearance?

Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active received FDA 510(k) clearance on 2024-09-17, under 510(k) number K240660.

Who is the listed applicant for Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active?

The FDA 510(k) record lists Kulzer, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active?

The FDA product code for Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active is EBF.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Kulzer, LLC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。

K260783维纳斯钻石；维纳斯钻石流；维纳斯珍珠；维纳斯大流量一K254063iCEM通用增强型K243910RetraxilK233868迪玛打印牙齿与温度计K230644Signum 不透明 FK220605维纳斯大流量ONE

查看所有 7 个设备 →

相关器械（代码：EBF）

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。

K262982Core·it 双核Spident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695流动修复材料（KP-Flow LF，KP-Flow MF，KP-Flow HF）Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228超越大体积填充流动复合树脂Ultradent Products, Inc.K261246SRGC-06GC America, Inc.

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。

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