TEMP MASTER, PMMA-based dental resin

TEMP MASTER is a self-curing PMMA-based dental resin for fabricating short-term temporary restorations including inlays, crowns, and bridges. It protects or restores damaged teeth while permanent restorations are being prepared, using a powder-liquid formulation that polymerizes at room temperature.

TEMP MASTER is a Type 1 (autopolymerizable) acrylic resin identical to the predicate in material composition and processing method. The main difference is slight variations in chemical composition percentage. Both devices meet the same physical property requirements: flexural strength >50 MPa, water absorption and solubility compliant with ISO 10477.

ISO 10477 (Dentistry—Polymer-based crown and bridge materials, 2018) for flexural strength, water sorption, and water solubility; ISO 10993 for biocompatibility evaluation per FDA Blue Book Memorandum #G95; ISO 868 for shelf-life testing.

Both TEMP MASTER and the predicate Unifast III are self-curing PMMA-based resins with identical indications for temporary crown and bridge fabrication. Performance testing under ISO 10477 demonstrates TEMP MASTER achieves equivalent mechanical and physical properties to the predicate. Biocompatibility testing per ISO 10993 confirms safety despite minor chemical composition differences. The similarity in material type, processing method, intended use, and demonstrated equivalent performance establishes substantial equivalence under product code EBG.