Luminesse 遮光氧化锆 SZ
K号: K152023 · 2016-09-15
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决定日期2016-09-15
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
Luminesse Shaded Zirconia SZ is the device name listed in this FDA 510(k) record. The listed applicant is Talladium, Inc.. It received FDA 510(k) clearance on 2016-09-15 under 510(k) number K152023. 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 Luminesse Shaded Zirconia SZ?
Luminesse Shaded Zirconia SZ is a medical device that received FDA 510(k) clearance on 2016-09-15. The listed applicant is Talladium, Inc.. The 510(k) number is K152023.
When did Luminesse Shaded Zirconia SZ receive FDA 510(k) clearance?
Luminesse Shaded Zirconia SZ received FDA 510(k) clearance on 2016-09-15, under 510(k) number K152023.
Who is the listed applicant for Luminesse Shaded Zirconia SZ?
The FDA 510(k) record lists Talladium, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Luminesse Shaded Zirconia SZ?
The FDA product code for Luminesse Shaded Zirconia SZ 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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