FDA 510(k)

Elos 精准® 混合底座™；Elos 精准® 定制基台

K号: K241722 · 2024-09-13

决定日期2024-09-13

产品代码NHA

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决定实质等同

器械摘要

Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Elos Medtech Pinol A/S. It received FDA 510(k) clearance on 2024-09-13 under 510(k) number K241722. 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 Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment?

Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment is a medical device that received FDA 510(k) clearance on 2024-09-13. The listed applicant is Elos Medtech Pinol A/S. The 510(k) number is K241722.

When did Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment receive FDA 510(k) clearance?

Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment received FDA 510(k) clearance on 2024-09-13, under 510(k) number K241722.

Who is the listed applicant for Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment?

The FDA 510(k) record lists Elos Medtech Pinol A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment?

The FDA product code for Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment is NHA.

列明Elos Medtech Pinol A/S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。

K253774Elos 精准® 假牙固定系统 K251497Elos 精准混合底座 K242025Elos 精准® 混合底座™K231307Elos 精准定制基台 K230317Elos 精准混合底座 K222044Elos 精准定制基台

查看所有 13 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.

官方来源

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