FDA 510(k)

Elos 精准定制基台

K号: K231307 · 2023-12-21

决定日期2023-12-21

产品代码NHA

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决定实质等同

器械摘要

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 2023-12-21 under 510(k) number K231307. 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 Customized Abutment?

Elos Accurate Customized Abutment is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Elos Medtech Pinol A/S. The 510(k) number is K231307.

When did Elos Accurate Customized Abutment receive FDA 510(k) clearance?

Elos Accurate Customized Abutment received FDA 510(k) clearance on 2023-12-21, under 510(k) number K231307.

Who is the listed applicant for 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 Customized Abutment?

The FDA product code for 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™K241722Elos 精准® 混合底座™；Elos 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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