免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据,仅供一般参考,不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

KLOCKNER VEGA 牙科植入系统

K号: K153098 · 2016-04-08

申请人SOADCO, S.L.
决定日期2016-04-08
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

KLOCKNER VEGA DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is SOADCO, S.L.. It received FDA 510(k) clearance on 2016-04-08 under 510(k) number K153098. 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 KLOCKNER VEGA DENTAL IMPLANT SYSTEM?

KLOCKNER VEGA DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2016-04-08. The listed applicant is SOADCO, S.L.. The 510(k) number is K153098.

When did KLOCKNER VEGA DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

KLOCKNER VEGA DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2016-04-08, under 510(k) number K153098.

Who is the listed applicant for KLOCKNER VEGA DENTAL IMPLANT SYSTEM?

The FDA 510(k) record lists SOADCO, S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KLOCKNER VEGA DENTAL IMPLANT SYSTEM?

The FDA product code for KLOCKNER VEGA DENTAL IMPLANT SYSTEM is DZE.

相关临床试验

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。

列明SOADCO, S.L.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。

相关器械(代码:DZE)

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。

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。

↑