G aenial Universal Injectable II

G-ænial Universal Injectable II is a light-cured, nano-filled radiopaque composite resin delivered in a syringe for multiple dental applications including direct restoration of anterior and posterior teeth, core build-up, adhesive cementation of ceramic and composite veneers/inlays/onlays, fissure sealing, and fabrication of orthodontic aligner attachments. It is available in nine shades and converts from paste to hard solid material upon light exposure.

The device is a light-cured resin composite with similar composition to the primary predicate (barium glass, dimethacrylate, initiator, pigment, silicon dioxide, stabilizer), containing approximately 46 vol% inorganic filler with particle size 0.01–0.5 μm, and radiopacity equivalent to 2.5–3.0 mm aluminum. It shares the same delivery form (paste in syringe) and curing mechanism as the primary predicate, though it expands indications to include cementation and aligner attachment uses covered by secondary and additional predicates.

ISO 4049:2019 (Dentistry – Polymer-based restorative materials, Type 1 and 2, Class 2, Group 1), ISO 6874:2015 (Dentistry – Polymer-based pit and fissure sealants, Class 2), ISO 10993-1:2018 and ISO 7405:2018 (Biocompatibility evaluation), and FDA guidance on Dental Composite Resin Devices and Dental Cements Performance Criteria.

The applicant device is substantially equivalent to the primary predicate (G-ænial Universal Injectable, K173500) because they have identical compositions, delivery form, light-curing mechanism, and overlapping indications 1–7. For indication 8 (adhesive cementation), the secondary predicate (G-CEM LinkForce, K153231) demonstrates SE through the same cementation mechanism with bonding material despite different curing mode. For indication 9 (aligner attachments), the additional predicate (AlignerFlow LC, K231817) demonstrates SE as a light-cured composite for the same application. Performance testing confirms all devices meet identical specifications for film thickness, depth of cure, flexural strength, water sorption, solubility, and other key properties.