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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.

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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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