FDA 510(k)

Oneday 埋入式基台

K号: K231753 · 2024-02-21

决定日期2024-02-21

产品代码NHA

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决定实质等同

器械摘要

Oneday Implant Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Oneday Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-02-21 under 510(k) number K231753. 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 Oneday Implant Abutment?

Oneday Implant Abutment is a medical device that received FDA 510(k) clearance on 2024-02-21. The listed applicant is Oneday Biotech Co., Ltd.. The 510(k) number is K231753.

When did Oneday Implant Abutment receive FDA 510(k) clearance?

Oneday Implant Abutment received FDA 510(k) clearance on 2024-02-21, under 510(k) number K231753.

Who is the listed applicant for Oneday Implant Abutment?

The FDA 510(k) record lists Oneday Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oneday Implant Abutment?

The FDA product code for Oneday Implant Abutment is NHA.

列明Oneday Biotech Co., Ltd.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。

K222946Oneday 微型埋入式系统

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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官方来源

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