Denture Base Resin DT20

Denture Base Resin DT20 is a light-curable, liquid polymerizable resin used to fabricate full and partial removable dentures in dental laboratories. The material is polymerized using a 3D printer (AccuFab-D1s or AccuFab-C1s) and post-curing unit (FabCure 2), requiring a digital denture file to produce the final denture base.

Both subject and predicate devices are light-curable methacrylate-based resins used with additive manufacturing for denture fabrication. The key difference is that the subject device contains no filler material, whereas the predicate device includes filler; however, performance testing confirms the subject device meets the same mechanical property standards as the predicate through acrylate-based alternatives.

ISO 20795-1:2013 (denture base polymers), ISO 7491:2000 (color stability), ISO 10993-1 (biocompatibility evaluation), ISO 7405 (denture base materials), and ASTM F1980-16 (shelf-life testing). Biocompatibility testing included cytotoxicity, sensitization, irritation, acute systemic toxicity, subacute/subchronic toxicity, implantation, pyrogenicity, and genotoxicity.

The subject device is substantially equivalent because it shares the same intended use (fabrication of removable dentures), regulatory classification (Class II, product code EBI), material type (light-curable resin), and curing method (UV light) as the predicate. Although the subject device omits fillers present in the predicate, performance bench testing demonstrates it meets all applicable ISO 20795-1 standards for denture base polymers, and biocompatibility testing was more comprehensive, addressing potential safety gaps. The minor compositional difference raises no new safety or effectiveness concerns.