FDA 510(k)

Ti-one 101 TS 牙科种植系统

K号: K172821 · 2018-06-11

决定日期2018-06-11

产品代码DZE

咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。

决定实质等同

器械摘要

Ti-one 101 TS Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Hung Chun Bio-S Co., Ltd.. It received FDA 510(k) clearance on 2018-06-11 under 510(k) number K172821. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ti-one 101 TS Dental Implant System?

Ti-one 101 TS Dental Implant System is a medical device that received FDA 510(k) clearance on 2018-06-11. The listed applicant is Hung Chun Bio-S Co., Ltd.. The 510(k) number is K172821.

When did Ti-one 101 TS Dental Implant System receive FDA 510(k) clearance?

Ti-one 101 TS Dental Implant System received FDA 510(k) clearance on 2018-06-11, under 510(k) number K172821.

Who is the listed applicant for Ti-one 101 TS Dental Implant System?

The FDA 510(k) record lists Hung Chun Bio-S Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ti-one 101 TS Dental Implant System?

The FDA product code for Ti-one 101 TS Dental Implant System is DZE.

列明Hung Chun Bio-S 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。

K151362HC 脊柱系统

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。