FDA 510(k)

Dentis s-Clean 标准牙槽基台

K号: K230126 · 2023-08-04

决定日期2023-08-04

产品代码NHA

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决定实质等同

器械摘要

Dentis s-Clean Regular Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Dentis Co., Ltd.. It received FDA 510(k) clearance on 2023-08-04 under 510(k) number K230126. 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 Dentis s-Clean Regular Abutment?

Dentis s-Clean Regular Abutment is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Dentis Co., Ltd.. The 510(k) number is K230126.

When did Dentis s-Clean Regular Abutment receive FDA 510(k) clearance?

Dentis s-Clean Regular Abutment received FDA 510(k) clearance on 2023-08-04, under 510(k) number K230126.

Who is the listed applicant for Dentis s-Clean Regular Abutment?

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

What is the FDA product code for Dentis s-Clean Regular Abutment?

The FDA product code for Dentis s-Clean Regular Abutment is NHA.

列明Dentis 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。

K253493Dentis SQ-SL AXEL 固定装置 K241065ChecQ (AC100)K233921Luvis 椅子 (LC700C)K241063s-Clean 扫描修复基台 K240511Dentis s-Clean SQ-SL 固定装置 K233544MESHEET

查看所有 31 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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