牙科氧化锆块
K号: K192262 · 2020-05-29
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决定日期2020-05-29
产品代码EIH
咨询委员会DE
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器械摘要
Dental Zirconia Blocks is the device name listed in this FDA 510(k) record. The listed applicant is De Corematrix Co., Ltd.. It received FDA 510(k) clearance on 2020-05-29 under 510(k) number K192262. 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 Zirconia Blocks?
Dental Zirconia Blocks is a medical device that received FDA 510(k) clearance on 2020-05-29. The listed applicant is De Corematrix Co., Ltd.. The 510(k) number is K192262.
When did Dental Zirconia Blocks receive FDA 510(k) clearance?
Dental Zirconia Blocks received FDA 510(k) clearance on 2020-05-29, under 510(k) number K192262.
Who is the listed applicant for Dental Zirconia Blocks?
The FDA 510(k) record lists De Corematrix Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dental Zirconia Blocks?
The FDA product code for Dental Zirconia Blocks 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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