FDA 510(k)

DenMat Bulk Fill Composite

K号: K242097 · 2024-10-15

决定日期2024-10-15

产品代码EBF

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决定实质等同

器械摘要

DenMat Bulk Fill Composite is the device name listed in this FDA 510(k) record. The listed applicant is Den-Mat Holdings, LLC. It received FDA 510(k) clearance on 2024-10-15 under 510(k) number K242097. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DenMat Bulk Fill Composite?

DenMat Bulk Fill Composite is a medical device that received FDA 510(k) clearance on 2024-10-15. The listed applicant is Den-Mat Holdings, LLC. The 510(k) number is K242097.

When did DenMat Bulk Fill Composite receive FDA 510(k) clearance?

DenMat Bulk Fill Composite received FDA 510(k) clearance on 2024-10-15, under 510(k) number K242097.

Who is the listed applicant for DenMat Bulk Fill Composite?

FDA 510(k)记录中列出Den-Mat Holdings, LLC为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for DenMat Bulk Fill Composite?

The FDA product code for DenMat Bulk Fill Composite is EBF.

列明Den-Mat Holdings, 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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