| K-number | K253337 |
| Device name | REGEN Bioactive Cement |
| Applicant | Inter-Med, Inc. |
| Product code | EMA |
| Device class | Class II |
| Decision date | Apr 15, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 872.3275 |
REGEN Bioactive Cement is a dual-component self-adhesive resin luting cement designed to bond indirect dental restorations (inlays, onlays, crowns, bridges, and endodontic posts) to teeth. The cement uses aerobic self-polymerization and photopolymerization and releases calcium and phosphate ions while bonded to tooth structure.
REGEN Bioactive Cement is a two-component, non-aqueous paste-like material in dual-barrel syringes with slightly different formulation than the predicate (Parkell Self-Adhesive Cement), though composition differences do not raise biocompatibility concerns. It features a heat-sealed foil pouch for long-term stability and has a 15-month shelf life at room temperature, compared to the predicate's 24-month shelf life.
Testing referenced ISO 4049 for setting time and flowability; ISO 10993-5:2009 for cytotoxicity testing; and ISO 14905:2018 for external communicating device permanent (≥30 days) contact classification.
REGEN Bioactive Cement has identical indications for use, identical intended population, identical mechanism of action (dual-component self-adhesive resin with structural and adhesive function), and substantially equivalent performance across non-clinical tests including setting time, flexural strength, water sorption, shear bond strength, film thickness, polymerized shrinkage, radiopacity, cytotoxicity, transit stability, and calcium/phosphate ion release compared to Parkell Self-Adhesive Cement predicate.
View the full FDA submission: accessdata.fda.gov