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Maxcem 2 is intended for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts, and veneers*. Additional indications include core-buildup material, pit and fissure sealant, and cementation of crown restorations to implants. * Adhesive application on the prep is required for veneer cementation using Maxcem 2.

Maxcem 2 is a self-etch, self-adhesive resin cement offered in a paste/paste formulation indicated for indirect cementation of ceramic, resin and metal restorations including veneers. This product contains 69% filler by weight and is radiopaque. The dual-cure material is packaged in dual barrel syringes with single-use automix tips and optional curved dispensing tips to allow the user to deliver the desired volume of cement directly into the restoration or tooth prep.

The provided text describes a 510(k) premarket notification for a dental cement called Maxcem 2. It does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document is a regulatory submission for a physical medical device (dental cement), not an AI/ML powered medical device.

Therefore, I cannot extract the requested information from the provided text for an AI/ML powered device.

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MaxCem is intended for indirect cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer indications.

The device is a self-etch adhesive resin cement offered in a paste/paste formulation indicated for the cementation of indirect ceramic, resin and metal restorations. Due to its self-etching and adhering properties, MaxCem does not require the use of an etchant, primer or adhesive. This product contains 68% filler by weight with an average filler particle size of 4 microns in the base formulation, is radiopaque and releases fluoride. The dual-cure material is packaged in automix dual barrel syringes which allow the user to deliver the desired volume of cement directly into the restoration or tooth cavity.

This document is a 510(k) premarket notification for a dental cement called MaxCem. It describes the device, its intended use, and claims substantial equivalence to an existing device (UniCem). This is primarily a regulatory filing and does not contain acceptance criteria or a study proving that the device meets acceptance criteria.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory approval based on substantial equivalence, rather than a performance study with defined acceptance criteria.

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