ZAFIRA®

ZAFIRA® is a light-cured composite resin material used for direct and indirect restoration of teeth. It is available in two formulations: a tooth-shade composite for anterior/posterior restorations, cervical restorations, and veneers; and a gum-shade composite for reproducing gingival tissue in prosthetic restorations including crowns, bridges, and implant restorations.

ZAFIRA® is a methacrylate-based composite resin dispensed from a reusable syringe and light-cured. It shares the same product code (EBF), regulation (21 CFR 872.3690), material type, mode of application, and single-use, prescription-only, non-sterile status as the predicate and reference devices. It is non-conductive, non-metallic, and non-magnetic.

Material properties tested to ISO 4049; biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), and ISO 10993-23 (irritation); accelerated shelf-life stability testing per sponsor's protocol.

ZAFIRA® is substantially equivalent to the predicate device (Tetric® PowerFill, K183380) and reference devices because it shares the same indications for use in dental restorations, identical technological characteristics as a light-cured methacrylate composite, same product code and regulation, and has demonstrated biocompatibility and performance testing to ISO 4049 meeting acceptance criteria. Minor differences in specific indications are mitigated by the comprehensive testing and the similarity of intended use across predicate and reference devices.