els unibond

els unibond is an extra low shrinkage, light-curing, single-component, self-etching dental adhesive used to bond tooth structure to light-curing composite filling or fixing materials. It is indicated for direct restorations with light-curing composite-based materials and indirect restorations using light-curing composite cements to fix inlays, onlays, crowns, and bridges.

els unibond is a light-cured, one-component resin-based adhesive composed of monomers, fillers, solvents, initiators, silanization agents, and stabilizers. It is supplied in a bottle as a yellow liquid that cures to a colorless solid. The device is non-sterile and prescription-only, with shear bond strengths ranging from 15.1 to 34.2 MPa depending on substrate and etching mode.

ISO 10993-1:2018 (Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process) and ISO 7405:2018 (Dentistry – Evaluation of Biocompatibility of Medical Devices Used in Dentistry). Shear bond strength testing was performed as non-clinical performance testing.

els unibond shares the same indications for use as predicate devices (K-Bond Universal, Scotchbond Universal, Adhese Universal DC), is a similarly composed resin-based adhesive with comparable physical properties and chemical components, and demonstrates shear bond strengths within the range of predicate devices across all substrate and etching modes tested. The differences in formulation do not impact safety and effectiveness.