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FDA 510(k)

ET修复连接体；ET扫描修复连接体；EK扫描修复连接体

K号: K253372 · 2026-05-14

申请人Hiossen, Inc.
决定日期2026-05-14
产品代码NHA
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决定实质等同

器械摘要

ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Hiossen, Inc.. It received FDA 510(k) clearance on 2026-05-14 under 510(k) number K253372. 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 ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments?

ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments is a medical device that received FDA 510(k) clearance on 2026-05-14. The listed applicant is Hiossen, Inc.. The 510(k) number is K253372.

When did ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments receive FDA 510(k) clearance?

ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments received FDA 510(k) clearance on 2026-05-14, under 510(k) number K253372.

Who is the listed applicant for ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments?

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 ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments?

The FDA product code for ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing 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。

K251427EK MULTI ANGLED 30 基台K241003HIOSSEN 预加工基台（ET 预加工基台 & EK 预加工基台）K240232EK D3.3 和超宽植入物K233389EK 数字基台K222636ET连接体系统K203360EK 植入物和基台系统

查看所有 16 个设备 →

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

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