Any-Core

Any-Core is a dual-cured composite resin material used for core build-up procedures and post cementation in dental applications. It is supplied in a dual-barrel syringe with automix tip for intraoral dispensing and is available in three shades (A3, White, Blue). Intended uses include repair of provisionals, cementation of pins and posts, and semipermanent restorative material for children's teeth.

Any-Core is a dual-cured composite with Bis-GMA resin matrix formulated with glass powder, TMPTMA, and initiators. It achieves polymerization via light-curing or self-curing with working time of approximately 3 minutes and setting time of 7.63 minutes. The device demonstrates flexural strength of 96.4 MPa, water absorption of 3.04 μg/mm³, solubility of 5.18 μg/mm³, and higher radiopacity than aluminum. Light curing uses 465 nm wavelength at 1,500 mW/cm² intensity.

ISO 4049 for performance testing (appearance, capacity, packaging, working time, curing time, flexural strength, color stability, water absorption, solubility, radiopacity). ISO 10993-1, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-11:2017 for biocompatibility evaluation. Shear bond strength testing also performed.

Any-Core is substantially equivalent to the predicate LuxaCore (K012307) because both devices share the same indications for use, product code (EBF), dual-cure mechanism, and technological characteristics. Although minor raw material differences exist, the comparable performance testing and biocompatibility results demonstrate equivalent safety and effectiveness profiles.