FDA 510(k)

G-BLOCK

K号: K253236 · 2025-09-29

决定日期2025-09-29

产品代码EBF

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决定实质等同

器械摘要

G-BLOCK is the device name listed in this FDA 510(k) record. The listed applicant is Graphenano Dental S.L.. It received FDA 510(k) clearance on 2025-09-29 under 510(k) number K253236. 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 G-BLOCK?

G-BLOCK is a medical device that received FDA 510(k) clearance on 2025-09-29. The listed applicant is Graphenano Dental S.L.. The 510(k) number is K253236.

When did G-BLOCK receive FDA 510(k) clearance?

G-BLOCK received FDA 510(k) clearance on 2025-09-29, under 510(k) number K253236.

Who is the listed applicant for G-BLOCK?

The FDA 510(k) record lists Graphenano Dental S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G-BLOCK?

The FDA product code for G-BLOCK is EBF.

列明Graphenano Dental S.L.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。

K220329G-CAM

官方来源

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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。