Quantium

Quantium is a light-cured, radiopaque, universal composite resin designed for tooth restoration. It is used for direct anterior and posterior restorations, core build-ups, splinting, and indirect restorations including inlays, onlays, and veneers. The device blends with tooth structure when used alone or in a layering technique.

Both Quantium and the predicate TrusFIL are methacrylate-based, radiopaque, light-cure pastes requiring a dental adhesive and available in syringe and unit-dose capsule formats. The key difference is that Quantium uses Ytterbium Fluoride as a filler, which is an industry-standard filler, whereas TrusFIL uses different fillers. All chemical components of Quantium are based on industry standard chemistry and are substantially equivalent in performance.

ISO 4049:2019 was used for nonclinical testing, including sensitivity to light, depth of cure, flexural strength, water sorption, shade/color stability, radiopacity, compressive strength, flexural modulus, and hardness after cure.

Quantium and TrusFIL are both methacrylate-based, radiopaque, light-cure universal composites with identical indications for use. Both require dental adhesive and come in syringe and unit-dose formats. Nonclinical testing demonstrated that Quantium performed equal to or better than the predicate and met ISO 4049:2019 requirements. The substitution of Ytterbium Fluoride filler does not change the intended use or fundamental performance characteristics, making Quantium substantially equivalent to TrusFIL.