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G-BLOCK

FDA 510(k)

Class II (US FDA 510(k))

510(k) K253236

by Graphenano Dental S.L.

Identifiers

510(k) Number
K253236 FDA 510(k)
FDA Product Code
EBF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3690 FDA 510(k)
Regulation Number
872.3690 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

G-BLOCK is a graphene nanoreinforced biopolymer block intended for the production of permanent and temporary restorations, including implant-supported prostheses, crowns, bridges, inlays, and veneers. These blocks offer increased flexibility and surface hardness with a specific weight equivalent to that of natural dentition.

G-BLOCK is supplied as a biopolymer block for use in CAD/CAM milling in restorative dentistry. The device is manufactured by Graphenano Dental S.L. and has received FDA 510K clearance with product code EBF. It is stored according to manufacturer specifications and is available in various sizes as indicated by the model number K253236.

Frequently asked questions

What is G-BLOCK used for in dental procedures?

G-BLOCK is a graphene nanoreinforced biopolymer block intended for producing permanent and temporary restorations, including implant-supported prostheses, crowns, bridges, inlays, and veneers. It offers increased flexibility and surface hardness similar to natural dentition.

How is G-BLOCK supplied and what sizes are available?

G-BLOCK is supplied as a biopolymer block specifically designed for CAD/CAM milling in restorative dentistry. It is available in various sizes as indicated by the model number K253236, allowing for customization based on specific dental restoration needs.

What is the regulatory status of G-BLOCK?

G-BLOCK has received FDA 510K clearance with product code EBF. This clearance indicates that the device is substantially equivalent to predicate devices already on the market for its intended use in dental restorations.

How should G-BLOCK be stored?

G-BLOCK should be stored according to the manufacturer's specifications to maintain its integrity and performance characteristics. Proper storage conditions help ensure the biopolymer block remains suitable for its intended use in dental CAD/CAM procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Graphenano Dental - Grupo Graphenano, Graphenano Dental | Shop, Graphenano Dental | Disco de biopolímero nanorreforzado con grafeno ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Graphenano Dental S.L.

Sources (1)

  • FDA 510(k) K253236 24 fields · synced Sep 28, 2026