FDA 510(k)

G-BLOCK

K-Number: K253236 · 2025-09-29

Decision Date2025-09-29

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

G-BLOCK is a medical device manufactured by Graphenano Dental S.L.. It received FDA 510(k) clearance on 2025-09-29 under approval number K253236. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G-BLOCK?

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

When was G-BLOCK approved by the FDA?

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

What company makes G-BLOCK?

G-BLOCK is manufactured by Graphenano Dental S.L..

What is the FDA product code for G-BLOCK?

The FDA product code for G-BLOCK is EBF.

Other Devices by Graphenano Dental S.L.

K220329G-CAM

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.