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AGC®Cem is a dental self-curing compomer cement for the permanent cementation of AGC® SupraCaps in tertiary structures such as secondary telescopic crowns in chrome cobalt substructures, or SupraCaps in implant supraconstructions.

AGC Cem is a dental luting material, which can be used by dental technicians to manufacture dental restorations. It is a two-component chemical (self)-curing compomer with a golden yellow color. AGC Cem is especially designed for the permanent luting of AGC SupraCaps, i.e. pure gold caps, which had been electroformed with the AGC® Galvanoforming technique, in tertiary structures to produce removable dentures. Possible uses of the AGC®Cem include luting of AGC® SupraCaps as telescopic crowns in chrome cobalt substructures and luting of AGC SupraCaps in implant supraconstructions. AGC Cem is offered in an Automix-System, that ensures automatic mixing of the two components. It generates a homogeneous material quality and allows direct application of the material. AGC Cem creates an excellent fit owing to its low film thickness and lead to high adhering strengths. Its golden yellow color provides an excellent basis to the dental technician to manufacture aesthetically pleasant dental restorations. AGC Cem fully complies to the international standard ISO 4049:2000 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.

The provided document is a 510(k) summary for a dental cement called AGC®Cem. It describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain information about acceptance criteria, a study proving device performance, sample sizes for test or training sets, expert qualifications, ground truth establishment, or any comparative effectiveness studies as requested in the prompt.

Therefore, I cannot fulfill the request for information on acceptance criteria and a study proving the device meets those criteria from the provided text.

The document mainly focuses on:

• Device description: AGC®Cem is a two-component chemical (self)-curing compomer with a golden yellow color, designed for permanent luting of AGC® SupraCaps.
• Intended Use: Luting of AGC® SupraCaps as telescopic crowns in chrome cobalt substructures and luting of AGC® SupraCaps in implant supraconstructions.
• Legal Equivalence: It is deemed substantially equivalent to Permacem (K012316).
• Compliance: States it complies with ISO 4049:2000 and European directive 93/42/ECC.

None of these sections detail a study with specific acceptance criteria and performance metrics in the way your prompt describes.

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