Bond-PR™ Universal Adhesive

Bond-PR™ Universal Adhesive is a light-cure, single-component dental bonding agent that combines etch, primer, and adhesive into one product. It is used for bonding composite materials to tooth structures and for indirect restorations, and can be applied using self-etch, selective-etch, or total-etch techniques.

The device is formulated as a light-cured, single-component adhesive containing dimethacrylate monomer, HEMA, phosphorylated methacrylate, ethyl alcohol, water, photo-initiator, and co-initiator. It is non-sterile with at least 24 months shelf life and available in bottle or unit dose formats. Composition is similar to the predicate (3M Scotchbond Universal Plus) with minor ingredient differences.

Performance testing followed FDA-recognized consensus standards for dental adhesives. Shear bond strength testing was conducted per ISO 29022 on etched and unetched dentin and enamel (human and bovine). Biocompatibility testing followed ISO 10993 standards, including cytotoxicity, skin sensitivity, irritation, acute systemic toxicity, and genotoxicity evaluations.

Bond-PR™ Universal Adhesive is substantially equivalent to the predicate 3M Scotchbond Universal Plus (ADH19, K192961) because both devices share identical indications for use, classification, product code, method of polymerization, and application method. Both are light-cured, single-component adhesives with equivalent technological characteristics and performance testing results showing no new safety or efficacy concerns.