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FDA 510(k)

iRoot BP 根修复生物聚合材料；iRoot FS 快速固化根修复材料；iRoot BP Plus 根修复材料

K号: K222992 · 2022-11-22

申请人Innovative Bioceramix, Inc.
决定日期2022-11-22
产品代码KIF
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决定实质等同

器械摘要

iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Bioceramix, Inc.. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K222992. 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 iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material?

iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Innovative Bioceramix, Inc.. The 510(k) number is K222992.

When did iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material receive FDA 510(k) clearance?

iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material received FDA 510(k) clearance on 2022-11-22, under 510(k) number K222992.

Who is the listed applicant for iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material?

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

What is the FDA product code for iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material?

The FDA product code for iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material is KIF.

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Innovative Bioceramix, Inc.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。

K231259iRoot SP Plus

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。

K262050Vioseal XSpident Co., Ltd.K253909NeoPEX™ 预混合充填膏NuSmile, Ltd.K261514氢氧化钙临时填充材料（KP-Cal）Guilin Kevin Peter Technology Co., Ltd.K261415注射用根管封闭剂（KP-Root SP）Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr Corporation

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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