Bonafix TWO - 牙科植入系统
K号: K162853 · 2017-07-14
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决定日期2017-07-14
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
Bonafix TWO - Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Bonafix Surgical and Dental Implants. It received FDA 510(k) clearance on 2017-07-14 under 510(k) number K162853. 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 Bonafix TWO - Dental Implant System?
Bonafix TWO - Dental Implant System is a medical device that received FDA 510(k) clearance on 2017-07-14. The listed applicant is Bonafix Surgical and Dental Implants. The 510(k) number is K162853.
When did Bonafix TWO - Dental Implant System receive FDA 510(k) clearance?
Bonafix TWO - Dental Implant System received FDA 510(k) clearance on 2017-07-14, under 510(k) number K162853.
Who is the listed applicant for Bonafix TWO - Dental Implant System?
The FDA 510(k) record lists Bonafix Surgical and Dental Implants as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bonafix TWO - Dental Implant System?
The FDA product code for Bonafix TWO - 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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