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FDA 510(k)

NUVO 种植系统 - NUVO 工具包箱

K号: K202515 · 2020-11-24

申请人Jjgc Industria E Comercio DE Materiais Dentarios S.A.
决定日期2020-11-24
产品代码KCT
咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同

器械摘要

NUVO Implant System – NUVO Instrument Kit Cases is the device name listed in this FDA 510(k) record. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. It received FDA 510(k) clearance on 2020-11-24 under 510(k) number K202515. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NUVO Implant System – NUVO Instrument Kit Cases?

NUVO Implant System – NUVO Instrument Kit Cases is a medical device that received FDA 510(k) clearance on 2020-11-24. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K202515.

When did NUVO Implant System – NUVO Instrument Kit Cases receive FDA 510(k) clearance?

NUVO Implant System – NUVO Instrument Kit Cases received FDA 510(k) clearance on 2020-11-24, under 510(k) number K202515.

Who is the listed applicant for NUVO Implant System – NUVO Instrument Kit Cases?

The FDA 510(k) record lists Jjgc Industria E Comercio DE Materiais Dentarios S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NUVO Implant System – NUVO Instrument Kit Cases?

The FDA product code for NUVO Implant System – NUVO Instrument Kit Cases is KCT.

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Jjgc Industria E Comercio DE Materiais Dentarios S.A.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。

K222026Neodent Implant System - Zirconia Implant SystemK223638Neodent Implant System - Helix Short Implant SystemK223662Neodent Implant System - Helix Short Surgical Kit CasesK220251Neodent Implant System - GM Narrow Implant SystemK210336Neodent Implant System - Zirconia Implant SystemK203542Neodent Implant System - Mini Abutment 60°

查看所有 28 个设备 →

相关器械（代码：KCT）

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。

K253988LiteSet托盘Nobel Biocare ABK261935外科和假肢托盘Dentsply Sirona, Inc.K253187SteriBest® 消毒托盘系统Mastel SurgicalK252854SteriTite 容器系统与 MediTray 产品Case Medical, Inc.K260726Straumann® ProClean™托盘（041.800；041.801）Institut Straumann AGK253791PUREVUE™ 快速连接导管系统托盘；PUREVUE™ 快速连接导管系统盖DePuy Mitek, 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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