陶瓷假牙氧化锆陶瓷块
K号: K181816 · 2018-11-29
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决定日期2018-11-29
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
Ceramic Denture Zirconia Ceramics Block is the device name listed in this FDA 510(k) record. The listed applicant is Qinhuangdao Silide Ceramic Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-11-29 under 510(k) number K181816. 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 Ceramic Denture Zirconia Ceramics Block?
Ceramic Denture Zirconia Ceramics Block is a medical device that received FDA 510(k) clearance on 2018-11-29. The listed applicant is Qinhuangdao Silide Ceramic Technology Co., Ltd.. The 510(k) number is K181816.
When did Ceramic Denture Zirconia Ceramics Block receive FDA 510(k) clearance?
Ceramic Denture Zirconia Ceramics Block received FDA 510(k) clearance on 2018-11-29, under 510(k) number K181816.
Who is the listed applicant for Ceramic Denture Zirconia Ceramics Block?
The FDA 510(k) record lists Qinhuangdao Silide Ceramic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ceramic Denture Zirconia Ceramics Block?
The FDA product code for Ceramic Denture Zirconia Ceramics Block is EIH.
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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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