氧化锆牙科陶瓷
K号: K170894 · 2017-08-01
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决定日期2017-08-01
产品代码EIH
咨询委员会DE
请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。
决定实质等同
器械摘要
Zirconia Dental Ceramics is the device name listed in this FDA 510(k) record. The listed applicant is Chengdu Besmile Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2017-08-01 under 510(k) number K170894. 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 Zirconia Dental Ceramics?
Zirconia Dental Ceramics is a medical device that received FDA 510(k) clearance on 2017-08-01. The listed applicant is Chengdu Besmile Biotechnology Co., Ltd.. The 510(k) number is K170894.
When did Zirconia Dental Ceramics receive FDA 510(k) clearance?
Zirconia Dental Ceramics received FDA 510(k) clearance on 2017-08-01, under 510(k) number K170894.
Who is the listed applicant for Zirconia Dental Ceramics?
The FDA 510(k) record lists Chengdu Besmile Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Zirconia Dental Ceramics?
The FDA product code for Zirconia Dental Ceramics 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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