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FDA 510(k)

HIOSSEN 预加工基台（ET 预加工基台 & EK 预加工基台）

K号: K241003 · 2025-01-08

申请人Hiossen, Inc.
决定日期2025-01-08
产品代码NHA
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决定实质等同

器械摘要

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) is the device name listed in this FDA 510(k) record. The listed applicant is Hiossen, Inc.. It received FDA 510(k) clearance on 2025-01-08 under 510(k) number K241003. 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 HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)?

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) is a medical device that received FDA 510(k) clearance on 2025-01-08. The listed applicant is Hiossen, Inc.. The 510(k) number is K241003.

When did HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) receive FDA 510(k) clearance?

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) received FDA 510(k) clearance on 2025-01-08, under 510(k) number K241003.

Who is the listed applicant for HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)?

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

What is the FDA product code for HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)?

The FDA product code for HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) 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Hiossen, 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。

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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。

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官方来源

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