FDA 510(k)

EK 数字基台

K号: K233389 · 2024-05-29

决定日期2024-05-29

产品代码NHA

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决定实质等同

器械摘要

EK Digital 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 2024-05-29 under 510(k) number K233389. 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 EK Digital Abutments?

EK Digital Abutments is a medical device that received FDA 510(k) clearance on 2024-05-29. The listed applicant is Hiossen, Inc.. The 510(k) number is K233389.

When did EK Digital Abutments receive FDA 510(k) clearance?

EK Digital Abutments received FDA 510(k) clearance on 2024-05-29, under 510(k) number K233389.

Who is the listed applicant for EK Digital 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 EK Digital Abutments?

The FDA product code for EK Digital Abutments is NHA.

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。

K253372ET修复连接体；ET扫描修复连接体；EK扫描修复连接体 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 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, LLC K253999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 AB K261147Neodent植入系统 - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061BioHorizons CEREC 兼容 Ti-BasesBioHorizons Implant Systems, Inc.

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