zirkon；结构；LFU色调、着色剂和釉料
K号: K251084 · 2025-06-05
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决定日期2025-06-05
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
zirkon; structure; LFU shades, stains and glazes is the device name listed in this FDA 510(k) record. The listed applicant is Estetic Ceram AG. It received FDA 510(k) clearance on 2025-06-05 under 510(k) number K251084. 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 zirkon; structure; LFU shades, stains and glazes?
zirkon; structure; LFU shades, stains and glazes is a medical device that received FDA 510(k) clearance on 2025-06-05. The listed applicant is Estetic Ceram AG. The 510(k) number is K251084.
When did zirkon; structure; LFU shades, stains and glazes receive FDA 510(k) clearance?
zirkon; structure; LFU shades, stains and glazes received FDA 510(k) clearance on 2025-06-05, under 510(k) number K251084.
Who is the listed applicant for zirkon; structure; LFU shades, stains and glazes?
The FDA 510(k) record lists Estetic Ceram AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for zirkon; structure; LFU shades, stains and glazes?
The FDA product code for zirkon; structure; LFU shades, stains and glazes is EIH.
相关临床试验
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。
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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