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 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.

Frequently Asked Questions

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.

Other records listing Graphenano Dental S.L. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220329G-CAM

Related Devices (Code: EBF)

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group International K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group International K260805Dual CoreVericom Co., Ltd.

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.