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510(k) Data Aggregation

    K Number
    K253236
    Device Name
    G-BLOCK
    Date Cleared
    2025-09-29

    (0 days)

    Product Code
    Regulation Number
    872.3690
    Panel
    Dental
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    G-BLOCK is intended to be used for the fabrication of permanent and temporary restorations such as dental implant prostheses, crowns, bridges, inlays, onlays and veneers.

    Device Description

    G-BLOCK is a compact block made of graphene-doped polymer suitable for the manufacture of dental prostheses using CAD/CAM technology. The polymer is based on polymethyl methacrylate (PMMA) doped with graphene (an allotrope of carbon).

    G-BLOCK is intended to be used for the fabrication of permanent and temporary restorations such as dental implant prostheses, crowns, bridges, inlays, onlays and veneers.

    G-BLOCK, compounded of polymethyl methacrylate (PMMA) doped with Graphene, is manufactured using the heat-curing method.

    G-BLOCK presents high modulus and elastic limit to ensure that the tensions generated during biting and chewing do not cause permanent deformations, and it is possible to manufacture prosthesis of smaller sections.

    G-BLOCK presents high deformation resistance and stress limit, thus avoiding the formation of cracks and fractures.

    G-BLOCK is low density making the prosthesis lightweight.

    G-BLOCK increases the material hardness comparing with acrylic resins used in dentistry.

    G-BLOCK has colour stability.

    G-BLOCK has wide chromatic range, even within the same piece, making it look extremely natural.

    G-BLOCK is chemically inert.

    G-BLOCK water absorption is 4 μg/mm³ and a solubility of 0.5 μg/mm². The release of residual monomer is minimum, with a percentage of 0.004% of residual monomer. Thanks to these physical properties G-BLOCK offers a durable and safety treatment.

    G-BLOCK is available in different formats, sizes and colors, having all variations the same physicochemical characteristics.

    The device is presented in the form of a polymer block glued to an aluminum pin that allows the device to be fixed on the milling machine so that the block can be milled to obtain dental prostheses with the use of specific CAD/CAM equipment.

    G-BLOCK is available in 2 different formats: MONOCHROMA and MULTICHROMA. Monochrome and Multichroma blocks may be both used for anatomical monolithic restorations.

    When machined, Monochroma and Multichroma present a different visual effect:

    • Monochroma, is made of a pure colour matching the dentin.

    • Multichroma, has a chromatic spectrum based on the natural colour imitating the optical effects of the natural dentition.

    Both variants are presented in two sizes: 14 and 40.

    G-BLOCK device is available in the following colours, A1, A2, A3, A3.5, B1, B2, BL1, BL2, C2 (according to G-CAM shade guide).

    G-BLOCK are provided non-sterile and as a single use device.

    G-BLOCK must be used only by professionals as dental lab technicians and / or dentist.

    G-BLOCK should be stored at room temperature in its original packaging, in dry storage and avoid exposure to direct sunlight. PMMA polymer from which the G-BLOCK is made is stable and can be stored for an extended period of 5-year shelf life.

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