GMI Frontier牙种植系统
K号: K161593 · 2017-01-19
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决定日期2017-01-19
产品代码DZE
咨询委员会DE
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器械摘要
GMI Frontier Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Ilerimplant S.L. It received FDA 510(k) clearance on 2017-01-19 under 510(k) number K161593. 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 GMI Frontier Dental Implant System?
GMI Frontier Dental Implant System is a medical device that received FDA 510(k) clearance on 2017-01-19. The listed applicant is Ilerimplant S.L. The 510(k) number is K161593.
When did GMI Frontier Dental Implant System receive FDA 510(k) clearance?
GMI Frontier Dental Implant System received FDA 510(k) clearance on 2017-01-19, under 510(k) number K161593.
Who is the listed applicant for GMI Frontier Dental Implant System?
The FDA 510(k) record lists Ilerimplant S.L as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GMI Frontier Dental Implant System?
The FDA product code for GMI Frontier 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。
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。
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