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Luting porcelain fused to metal crowns and bridges to tooth structure, amalgam, composite or glass ionomer core build ups;

Luting metal inlays, onlays or crowns;

Luting pre-fabricated and cast post cementation

Luting orthodontic appliances

Luting crowns made with all-alumina or allzirconia cores such as Procera® AllCeram

RelyX RMGIP cement is a self-curing, radiopaque, fluoride-releasing, resin-modified glass ionomer luting cement. The cement consists of a base and catalyst paste packaged in the 3M ESPE Clicker dispensing system. RelyX RMGIP is available in a white shade.

This is a 510(k) premarket notification for a dental cement (RelyX RMGIP). The provided information does not contain details about acceptance criteria, device performance, a test set, ground truth experts, adjudication methods, or multi-reader multi-case studies.

The document describes modifications to an existing device (RelyX Luting Cement) and demonstrates substantial equivalence to predicate devices based on:

• Intended Use: Same as predicate.
• Major Chemical Components: Same as predicate.
• Shelf Life and Storage Conditions: Same as predicate.
• Safety: Demonstrated through comparison of chemical composition to RelyX Luting Cement and biocompatibility testing by independent research institutes.
• Effectiveness: Demonstrated by comparing performance characteristics of RelyX RMGIP to RelyX Luting Cement and GC FujiCEM.

The document focuses on physical and chemical properties and their equivalence to existing devices, not on a study with "acceptance criteria" and "reported device performance" in the typical sense of a diagnostic or AI-driven device.

Therefore, I cannot provide the requested table and information based on the given input, as it does not exist in the provided text.

The closest information provided is:

• Training Set (Implied): The "predicate device" and "existing powder/liquid systems" of RelyX Luting Cement could be considered an historical or existing "training set" of performance, as the new device is compared against its established characteristics.
• Ground Truth for Training Set (Implied): The "excellent physical, mechanical and clinical properties" of the existing RelyX Luting Cement serve as the established "ground truth" against which the new device's performance is compared for effectiveness. This would have been established through prior testing and clinical use of the predicate devices.

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