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EnaCem is a dual curing radiopaque fluorescent luting composite, available in several dentine colours, for cementation of posts, ceramic and composite inlay, onlay veneers and crowns. It can be used also for core build-up and as a liner.

The ENA CEM is a luting material available in a flowable consistency (Ena Cem) and also in a high viscous version (Ena Cem HF) that is available in different colours. Both can be used for cementing prosthesis appliances made in laboratory to the tooth. They can be used also for post-cementation. Ena Cem HF can also be used for core build-up and as a liner. The accessories and try-in materials contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally.

The provided text is a 510(k) summary for a dental cement (ENA CEM) and does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets such criteria. It primarily focuses on the classification, description, and substantial equivalence of the dental cement to existing products.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving their fulfillment based on the provided text. The document is about regulatory approval of a dental cement, not the performance evaluation of an AI/software device.

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