FDA 510(k)

DenMat Multilayered Zirconia Disc

K号: K251593 · 2025-08-25

决定日期2025-08-25

产品代码EIH

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决定实质等同

器械摘要

DenMat Multilayered Zirconia Disc is the device name listed in this FDA 510(k) record. The listed applicant is Denmat Holding, LLC. It received FDA 510(k) clearance on 2025-08-25 under 510(k) number K251593. 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 DenMat Multilayered Zirconia Disc?

DenMat Multilayered Zirconia Disc is a medical device that received FDA 510(k) clearance on 2025-08-25. The listed applicant is Denmat Holding, LLC. The 510(k) number is K251593.

When did DenMat Multilayered Zirconia Disc receive FDA 510(k) clearance?

DenMat Multilayered Zirconia Disc received FDA 510(k) clearance on 2025-08-25, under 510(k) number K251593.

Who is the listed applicant for DenMat Multilayered Zirconia Disc?

The FDA 510(k) record lists Denmat Holding, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DenMat Multilayered Zirconia Disc?

The FDA product code for DenMat Multilayered Zirconia Disc is EIH.

列明Denmat Holding, LLC为申报人的其他记录

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。

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官方来源

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