Z7氧化锆植入系统
K号: K221488 · 2023-06-26
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申请人Z7, LLC
决定日期2023-06-26
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
Z7 Zirconia Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Z7, LLC. It received FDA 510(k) clearance on 2023-06-26 under 510(k) number K221488. 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 Z7 Zirconia Implant System?
Z7 Zirconia Implant System is a medical device that received FDA 510(k) clearance on 2023-06-26. The listed applicant is Z7, LLC. The 510(k) number is K221488.
When did Z7 Zirconia Implant System receive FDA 510(k) clearance?
Z7 Zirconia Implant System received FDA 510(k) clearance on 2023-06-26, under 510(k) number K221488.
Who is the listed applicant for Z7 Zirconia Implant System?
The FDA 510(k) record lists Z7, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Z7 Zirconia Implant System?
The FDA product code for Z7 Zirconia Implant System is DZE.
相关临床试验
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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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