免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

Neodent Implant System - Custom Abutments

K号: K250614 · 2025-05-27

申请人Jjgc Indústria E Comércia DE Materiais Dentários S.A.
决定日期2025-05-27
产品代码NHA
咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。
决定实质等同

器械摘要

Neodent Implant System - Custom Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Jjgc Indústria E Comércia DE Materiais Dentários S.A.. It received FDA 510(k) clearance on 2025-05-27 under 510(k) number K250614. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Neodent Implant System - Custom Abutments?

Neodent Implant System - Custom Abutments is a medical device that received FDA 510(k) clearance on 2025-05-27. The listed applicant is Jjgc Indústria E Comércia DE Materiais Dentários S.A.. The 510(k) number is K250614.

When did Neodent Implant System - Custom Abutments receive FDA 510(k) clearance?

Neodent Implant System - Custom Abutments received FDA 510(k) clearance on 2025-05-27, under 510(k) number K250614.

Who is the listed applicant for Neodent Implant System - Custom Abutments?

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

What is the FDA product code for Neodent Implant System - Custom Abutments?

The FDA product code for Neodent Implant System - Custom Abutments is NHA.

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 Indústria E Comércia DE Materiais Dentários 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。

K242686Neodent Implant System

相关器械（代码：NHA）

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。

K262207水泥固定基台Unidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLCK253999通用底座 ASC 启动；通用底座 ASC 非启动；通用底座 MUA ASC；临时基台 启动和非启动；愈合基台 锥形连接；Omnigrip 临床螺丝钛；Omnigrip 假体螺丝Nobel Biocare ABK261147Neodent植入系统 - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC 兼容 Ti-BasesBioHorizons Implant Systems, Inc.

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。

↑