Sil-Flow

Sil-Flow is a flowable light-cured temporary filling material used for filling and sealing in dental applications. It has seven indicated uses including temporary inlay/onlay treatments, sealing implant screw openings, relining temporary crowns/bridges, block-out material, gingival margin coverage, matrix fixation, and temporary cavity filling.

Sil-Flow contains Bis-GMA, Urethane Dimethacrylate, Hydroxethylmethylacrylate, Silicon dioxide, Camphorquinone, Ethyl-4 Dimethyl amino benzoate, and Butylated hydroxy toluene. It achieves 52 Shore D surface hardness, water sorption <40 µg/mm³, water solubility <7.5 µg/mm³, depth of cure 3.1mm, and has a 3-year shelf life.

ISO 4049 was used for visual appearance, depth of cure, Shore hardness D, sensitivity to ambient light, water sorption, water solubility, color stability, and shade stability testing. Additional biocompatibility testing per ISO 10993-05 (cytotoxicity), ISO 10993-10 (irritation and sensitization), and ISO 10993-11 (acute systemic toxicity) were conducted.

Sil-Flow shares identical indications for use with the predicate device (Clip Flow K153493), contains very similar active ingredients (both have Bis-GMA, Urethane Dimethacrylate, Hydroxethylmethylacrylate, Silicon dioxide, and similar photoinitiators), and meets the same ISO 4049 physical parameter standards for temporary filling materials. Both devices operate via the same filling and sealing mechanism with comparable shelf life testing protocols, making minor compositional differences immaterial to substantial equivalence.