Once-Fil Flow

Once-Fil Flow is a light-curing tooth-shade resin material designed for temporary dental restorations. It provides interim solutions before final prosthesis placement, serving functions such as pulp protection, maintaining tooth position, and temporary fillings in cavities and inlay/onlay cases. The device is available in two shades (Yellow for anterior teeth and Blue for visual contrast) and is applied by preparing the tooth surface, applying material, and light-curing it.

Once-Fil Flow shares the same light-curing mechanism, indications for use, biocompatibility, delivery system (syringe with disposable tip), period of use (prolonged exposure up to 30 days), and shelf-life (3 years) as the predicate device Clip Flow. Minor differences exist in raw material composition and some performance metrics (curing depth 4.3 mm vs. 4 mm; water absorption 32 µg/mm³ vs. unspecified; solubility 5 µg/mm³ vs. 18.4 µg/mm³), but both conform to ISO 4049 standards.

ISO 4049 (appearance, weight, packaging, sensitivity to ambient light, curing depth, water sorption/solubility, color and color stability, Shore D hardness); ISO 868 (Shore D hardness); ISO 10993-1 (biological evaluation and risk management); ISO 10993-5:2009 (in vitro cytotoxicity); ISO 10993-21:2021 (irritation tests); ISO 10993-11:2017 (systemic toxicity); ISO 10993-10:2021 (skin sensitization).

The subject device and predicate device have identical indications for use, intended users (licensed dentists), curing type (light-curing), and shelf-life. Although the subject device has slightly different raw material compositions, the performance test results (particularly curing depth, biocompatibility) and biocompatibility testing demonstrate safety and effectiveness equivalent to the predicate. The minor material differences do not raise safety or effectiveness concerns, supporting substantial equivalence.