| K-number | K250156 |
| Device name | Choice 2 DC |
| Applicant | Bisco, Inc. |
| Product code | EMA |
| Device class | Class II |
| Decision date | Jul 11, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 872.3275 |
Choice 2 DC is a dual-cured, resin luting/veneering cement formulated for cementing indirect dental restorations. It is used to cement crowns, fixed bridges, inlays, onlays, endodontic posts, cement-retained implant restorations, and veneers made from materials such as glass ceramic, lithium disilicate, porcelain, composite, metal, or zirconia.
Choice 2 DC is a color-stable, dual-cured, paste/paste form cement with similar technological characteristics to the predicate Duo-Link Universal and reference device Variolink Esthetic DC. All three devices are dual-cured, paste/paste formulations, radiopaque, use dental adhesive, and are supplied in dual-syringe format. The chemical composition of Choice 2 DC is based on industry standard chemistry and is similar to the predicate and reference devices.
Testing was performed according to ISO 4049:2019, which evaluated film thickness, working time, setting time, flexural strength, water sorption, water solubility, shade/color stability, and radiopacity. Shear bond strength testing was conducted per ISO 29022:2013. Biological safety was assessed using ISO 7405:2018 and ISO 10993-1:2018.
Choice 2 DC demonstrates substantial equivalence through identical indications for use and similar technological characteristics to the predicate device Duo-Link Universal. Nonclinical testing showed Choice 2 DC performed at least equal to both the predicate and reference devices across all ISO 4049:2019 parameters and met all requirements, establishing that it is as safe and effective while performing at least as well as the predicate and reference devices.
View the full FDA submission: accessdata.fda.gov