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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 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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G-CAM discs are intended to be used for the manufacture of full and partial removable dentures as well as permanent and temporary restorations such as anterior or posterior crowns and bridges, inlays, veneers, copings and substructures.

G-CAM is a thermoplastic acrylic disc made by a principal base of polymethyl methacrylate (PMMA) resin doped with graphene (allotropic form of carbon), suitable for the creation of dental prostheses using CAD/CAM technology.

G-CAM discs are intended to be used for the manufacture of full and partial removable dentures, implant overdentures as well as permanent and temporary restorations such as anterior or posterior crowns and bridges, inlays, onlays, veneers, copings and substructures.

The provided text describes a 510(k) premarket notification for a dental device called G-CAM. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through extensive human studies. Therefore, the information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" will largely relate to non-clinical performance testing against recognized standards and comparison with predicate devices, as clinical human-in-the-loop studies were explicitly not performed.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance for G-CAM

The acceptance criteria for G-CAM are primarily based on demonstrating substantial equivalence to predicate devices through conformity with recognized international standards for dental materials.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" in a traditional sense with numerical targets before the results. Instead, it provides a comparison table (Table 1) that lists the G-CAM's characteristics and its measured performance against the relevant ISO standards, alongside the characteristics of the predicate devices. The "acceptance" is implied by meeting or exceeding the minimum requirements of the specified ISO standards, and by showing substantial equivalence to the predicate devices.

Table.1 Comparison of G-CAM with Predicate and Reference Devices (with performance data)

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