AlphaDent 牙齿种植系统
K号: K180968 · 2019-07-03
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决定日期2019-07-03
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
AlphaDent Implants Dental Implants System is the device name listed in this FDA 510(k) record. The listed applicant is Alphadent Implants, Ltd.. It received FDA 510(k) clearance on 2019-07-03 under 510(k) number K180968. 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 AlphaDent Implants Dental Implants System?
AlphaDent Implants Dental Implants System is a medical device that received FDA 510(k) clearance on 2019-07-03. The listed applicant is Alphadent Implants, Ltd.. The 510(k) number is K180968.
When did AlphaDent Implants Dental Implants System receive FDA 510(k) clearance?
AlphaDent Implants Dental Implants System received FDA 510(k) clearance on 2019-07-03, under 510(k) number K180968.
Who is the listed applicant for AlphaDent Implants Dental Implants System?
The FDA 510(k) record lists Alphadent Implants, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AlphaDent Implants Dental Implants System?
The FDA product code for AlphaDent Implants 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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