Fit & Brilliant 牙种植体系统
K号: K190637 · 2020-06-19
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决定日期2020-06-19
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
Fit & Brilliant Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is F&B Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-06-19 under 510(k) number K190637. 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 Fit & Brilliant Dental Implant System?
Fit & Brilliant Dental Implant System is a medical device that received FDA 510(k) clearance on 2020-06-19. The listed applicant is F&B Technology Co., Ltd.. The 510(k) number is K190637.
When did Fit & Brilliant Dental Implant System receive FDA 510(k) clearance?
Fit & Brilliant Dental Implant System received FDA 510(k) clearance on 2020-06-19, under 510(k) number K190637.
Who is the listed applicant for Fit & Brilliant Dental Implant System?
The FDA 510(k) record lists F&B Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fit & Brilliant Dental Implant System?
The FDA product code for Fit & Brilliant Dental Implant 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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