牙科陶瓷
K号: K182350 · 2019-05-22
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决定日期2019-05-22
产品代码EIH
咨询委员会DE
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决定实质等同
器械摘要
Dental Ceramic is the device name listed in this FDA 510(k) record. The listed applicant is Baot Biological Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-05-22 under 510(k) number K182350. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Dental Ceramic?
Dental Ceramic is a medical device that received FDA 510(k) clearance on 2019-05-22. The listed applicant is Baot Biological Technology Co., Ltd.. The 510(k) number is K182350.
When did Dental Ceramic receive FDA 510(k) clearance?
Dental Ceramic received FDA 510(k) clearance on 2019-05-22, under 510(k) number K182350.
Who is the listed applicant for Dental Ceramic?
The FDA 510(k) record lists Baot Biological Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dental Ceramic?
The FDA product code for Dental Ceramic is EIH.
相关临床试验
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相关器械（代码：EIH）
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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