EQUIA LC ONE

EQUIA LC ONE is a resin-modified glass ionomer dental restorative material used for direct dental restorations (Class I–V), root surface restoration, and core build-up. It is supplied as a powder/liquid formulation in a mixing capsule that sets through chemical reaction and light polymerization.

The device uses the same technological principles as predicate devices: curing via chemical reaction between fluoro-alumino-silicate glass and polycarboxylic acid aqueous solution, combined with monomer polymerization. The carboxylate groups of polyacrylic acid create chemical bonds to tooth calcium, similar to existing resin-modified glass ionomer cements.

ISO 9917-2:2017 (Dentistry – Water-based cements – Part 2: Resin-modified cements, Class 3, Restoration) and ISO 10993-1:2018 (Biological evaluation of medical devices). Biocompatibility testing per ISO 10993-3, 10993-5, 10993-6, 10993-10, 10993-11, 10993-12, and 10993-23.

The applicant device has identical indications for use (Class I–V restorations, root surface restoration, core build-up) to the primary predicate (Pulpdent RMGI Fill), which explicitly covers these restorations. It uses the same technological platform (resin-modified glass ionomer chemistry) with identical curing mechanisms. Performance bench testing and biocompatibility assessment conform to the same ISO standards as predicate devices, demonstrating no differences in safety and effectiveness when used as labeled.