ABC 牙齿种植系统
K号: K202092 · 2021-09-23
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决定日期2021-09-23
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
ABC Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Abracadabra Implants , Ltd.. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K202092. 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 ABC Dental Implant System?
ABC Dental Implant System is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Abracadabra Implants , Ltd.. The 510(k) number is K202092.
When did ABC Dental Implant System receive FDA 510(k) clearance?
ABC Dental Implant System received FDA 510(k) clearance on 2021-09-23, under 510(k) number K202092.
Who is the listed applicant for ABC Dental Implant System?
The FDA 510(k) record lists Abracadabra Implants , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ABC Dental Implant System?
The FDA product code for ABC Dental 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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