FDA 510(k)

KJ 氧化锆植入系统

K号: K173116 · 2018-06-28

决定日期2018-06-28

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

KJ ZIRCONIA Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Kj Meditech Co., Ltd.. It received FDA 510(k) clearance on 2018-06-28 under 510(k) number K173116. 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 KJ ZIRCONIA Implant System?

KJ ZIRCONIA Implant System is a medical device that received FDA 510(k) clearance on 2018-06-28. The listed applicant is Kj Meditech Co., Ltd.. The 510(k) number is K173116.

When did KJ ZIRCONIA Implant System receive FDA 510(k) clearance?

KJ ZIRCONIA Implant System received FDA 510(k) clearance on 2018-06-28, under 510(k) number K173116.

Who is the listed applicant for KJ ZIRCONIA Implant System?

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

What is the FDA product code for KJ ZIRCONIA Implant System?

The FDA product code for KJ ZIRCONIA Implant System is DZE.

列明Kj Meditech 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。

K202046LOTA SLA Dental Implant System and LOTA HA Dental Implant System K161923J2A SLA牙种植系统 K151970KJ 微型植入系统

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。