Cleared Abbreviated

G-BLOCK

K253236 · Graphenano Dental S.L. · Dental

Sep 2025

Decision

—

Days

Class 2

Risk

About This 510(k) Submission

K253236 is an FDA 510(k) clearance for the G-BLOCK, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Graphenano Dental S.L. (Valencia, ES). The FDA issued a Cleared decision on September 29, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K253236 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2025
Decision Date	September 29, 2025
Days to Decision	—
Submission Type	Abbreviated
Review Panel	Dental (DE)
Summary	Summary PDF