FDA 510(k)

OsteoCentric 牙科植入系统

K号: K230242 · 2023-10-05

决定日期2023-10-05

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

OsteoCentric Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is OsteoCentric Technologies. It received FDA 510(k) clearance on 2023-10-05 under 510(k) number K230242. 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 OsteoCentric Dental Implant System?

OsteoCentric Dental Implant System is a medical device that received FDA 510(k) clearance on 2023-10-05. The listed applicant is OsteoCentric Technologies. The 510(k) number is K230242.

When did OsteoCentric Dental Implant System receive FDA 510(k) clearance?

OsteoCentric Dental Implant System received FDA 510(k) clearance on 2023-10-05, under 510(k) number K230242.

Who is the listed applicant for OsteoCentric Dental Implant System?

The FDA 510(k) record lists OsteoCentric Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OsteoCentric Dental Implant System?

The FDA product code for OsteoCentric Dental Implant System is DZE.

列明OsteoCentric Technologies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。

K251913OsteoCentric® UnifiMI® TCS 接骨板系统 K250494OsteoCentric骨板和螺钉系统 K242691OsteoCentric Technologies 穿刺固定器和螺母 K230226Integrity-SI® Fusion System K230595OsteoCentric ACL 固定系统 K230764OsteoCentric 集成髋关节固定器系统

查看所有 11 个设备 →

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。