TopCEM Vigor SA Self-Adhesive Resin Cement

TopCEM Vigor SA Self-Adhesive Resin Cement is a dual-curing luting cement (chemical and/or light cure) used for cementing crowns, bridges, inlays, onlays, dental posts, fiber posts, and restorations on implant abutments. It is supplied as a paste-paste formulation in double-barrel syringes with approximately 40% inorganic filler loading and is radiopaque for visibility on radiographs.

Both the subject device and predicate device (3M ESPE AG Malta, K100756) contain methacrylate resins, phosphorylated methacrylate (MDP), silane-treated glass powder, silane-treated silica, pigments, initiators, and stabilizers. Both are supplied as dual-cure systems in syringe form with radiopaque properties conforming to ISO 4049 Type 2 Class 3. Minor differences exist in material composition, but these do not affect intended use or substantial equivalence.

Physical properties were tested according to ISO 4049, ISO 29022, ISO/TS 11405, and HUGE SOP, measuring working time, setting time, film thickness, flexural strength, water sorption, solubility, compressive strength, elastic modulus, surface hardness, shear bond strength, bonding durability, and radio-opacity. Biocompatibility testing followed ISO 7405 and ISO 10993 standards.

The subject device demonstrates substantial equivalence to the predicate because both have identical curing mechanisms (polymerization of methacrylate esters via photo and chemical initiators), identical indications for use, same delivery form and physical properties, and test results showing qualification comparable to the predicate. The predicate has been legally marketed with no clinical adverse events, and the subject device contains no non-conventional chemicals compared to the predicate.