ALFA GATE牙种植系统
K号: K182143 · 2019-10-03
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决定日期2019-10-03
产品代码DZE
咨询委员会DE
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决定实质等同
器械摘要
ALFA GATE Dental Implants System is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Gate Mazen, Ltd.. It received FDA 510(k) clearance on 2019-10-03 under 510(k) number K182143. 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 ALFA GATE Dental Implants System?
ALFA GATE Dental Implants System is a medical device that received FDA 510(k) clearance on 2019-10-03. The listed applicant is Alfa Gate Mazen, Ltd.. The 510(k) number is K182143.
When did ALFA GATE Dental Implants System receive FDA 510(k) clearance?
ALFA GATE Dental Implants System received FDA 510(k) clearance on 2019-10-03, under 510(k) number K182143.
Who is the listed applicant for ALFA GATE Dental Implants System?
The FDA 510(k) record lists Alfa Gate Mazen, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ALFA GATE Dental Implants System?
The FDA product code for ALFA GATE Dental Implants System is DZE.
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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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