OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment

OverCEM is a dual-curing, self-adhesive resin luting cement used for definitive cementation of dental restorations including inlays, onlays, crowns, bridges, endocanal posts, and implant-supported restorations. The cement consists of two pastes (A and B) in a one-body syringe that are automixed and polymerize through both self-curing and light-curing mechanisms.

OverCEM is a self-adhesive dual-curing cement (self-curing and light-curing) that requires no separate primer or adhesive component, unlike the predicate G-CEM ONE which requires a separate G-CEM ONE ADHESIVE ENHANCING PRIMER for optimized self-curing. Both devices use methacrylate chemistry with polymerization initiators in Paste A and B, plus photo-polymerization initiators. The paste ratio differs: OverCEM is 1.0 (w/w) versus G-CEM ONE's 1.3/1.0 ratio.

ISO 4049:2009 (polymer-based restorative materials), ISO 13116:2015 (radio-opacity), ISO 7491:2000 (color stability), ISO 29022:2013 (notched-edge shear bond strength), ISO 10993-1:2021 (biocompatibility), ISO 10993-5:2009 (cytotoxicity), and ISO 10993-10:2010 (skin sensitization and intracutaneous reactivity).

OverCEM is substantially equivalent because it shares the same polymerization mechanism and comparable raw materials with G-CEM ONE, performs the same cementation function, and demonstrates similar performance across key parameters (flexural strength 102.25 vs. 150 MPa, film thickness 23.10 vs. 5 µm, working/setting times in comparable ranges). The adhesion strength results to various substrates (dentin, enamel, zirconia, glass ceramic, composite, metal) are clinically similar to the predicate. Although OverCEM eliminates the need for a separate primer by incorporating dual-cure capability, this represents an improvement in convenience rather than a fundamental change in intended use or safety profile.