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FDA 510(k)

MIS C1 窄平台锥形连接植入系统，MIS C1 宽平台锥形连接基台

K号: K172505 · 2017-12-28

申请人Mis Implants Technologies , Ltd.
决定日期2017-12-28
产品代码DZE
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决定实质等同

器械摘要

MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Mis Implants Technologies , Ltd.. It received FDA 510(k) clearance on 2017-12-28 under 510(k) number K172505. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments?

MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments is a medical device that received FDA 510(k) clearance on 2017-12-28. The listed applicant is Mis Implants Technologies , Ltd.. The 510(k) number is K172505.

When did MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments receive FDA 510(k) clearance?

MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments received FDA 510(k) clearance on 2017-12-28, under 510(k) number K172505.

Who is the listed applicant for MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments?

The FDA 510(k) record lists Mis Implants Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments?

The FDA product code for MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments is DZE.

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Mis Implants Technologies , 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。

K182228MIS LOCKiT 基台系统，OT-等距器和球附件K180282MIS 内六角牙齿植入系统K173326MIS CONNECT 锥形连接基台K163349MIS V3 锥形连接牙齿植入系统

相关器械（代码：DZE）

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。

K261392TriActive 牙齿种植系统Paragon Implant Mfg., LLCK260463ZEROS 牙齿种植系统Zeros Co., Ltd.K251188UNIQA® 牙齿种植系统Uniqa Dental, Ltd.K251232MegaGen颧骨牙科植入系统Megagen Implant Co., Ltd.K250806牙科植入系统A.B. Dental Devices , Ltd.K260006INOSS 系统Inosys, Inc.

官方来源

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