Search Results

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.

Ask a specific question about this device