Adhese 2

Adhese 2 is a dual-curing, single-component dental adhesive for enamel and dentin compatible with all etching techniques (self-etch, selective-enamel-etch, and etch & rinse). It is used for adhesive cementation of indirect restorations, direct restorative procedures, and desensitization of hypersensitive cervical areas. The device is available in VivaPen, bottle, or Free Stand Single Dose units and can be light-cured at multiple intensities or self-cured in combination with luting composites.

Adhese 2 differs from the predicate Adhese Universal DC primarily in delivery form: it is newly available in the VivaPen format with initiator-coated cannulas, in addition to bottles and single-dose units. The chemical formulation is slightly modified. Light-curing specifications show higher shear bond strength values (≥25 MPa) compared to self-curing (≥20 MPa), and the device supports a 3-second cure mode at 2,700–3,300 mW/cm² with Bluephase PowerCure for posterior restorations.

EN 1641:2009 (Dentistry – Medical devices for dentistry – Materials) and ISO 29022:2013 (Dentistry – Adhesion – Notched-edge shear bond strength test). Biocompatibility evaluated per ISO 10993, ISO 7405, ISO 21726:2019, and ISO 14971:2019.

Adhese 2 is substantially equivalent to the predicate Adhese Universal DC because both are dual-curing dental adhesives with the same indications, contraindications, and working principles. While Adhese 2 introduces a new VivaPen delivery form and slightly modified formulation, these differences are not clinically significant. Biocompatibility testing confirms equivalence, device performance meets specification criteria, and long-standing clinical use of similar materials supports safety and efficacy.