FDA 510(k)

Elos 精准混合底座

K号: K251497 · 2025-10-16

决定日期2025-10-16

产品代码NHA

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决定实质等同

器械摘要

Elos Accurate Hybrid Base 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 2025-10-16 under 510(k) number K251497. 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 Hybrid Base is a medical device that received FDA 510(k) clearance on 2025-10-16. The listed applicant is Elos Medtech Pinol A/S. The 510(k) number is K251497.

When did Elos Accurate Hybrid Base receive FDA 510(k) clearance?

Elos Accurate Hybrid Base received FDA 510(k) clearance on 2025-10-16, under 510(k) number K251497.

Who is the listed applicant for Elos Accurate Hybrid Base?

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?

The FDA product code for Elos Accurate Hybrid Base 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 K242025Elos 精准® 混合底座™K241722Elos 精准® 混合底座™；Elos 精准® 定制基台 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。

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