Denture Base

Denture Base is a light-curable polymerizable resin used for fabricating and repairing full and partial removable dentures and denture baseplates. It is an alternative to traditional denture base material and is used exclusively by clinicians in dental offices in conjunction with 3D printing and scanning technology.

The device uses methacrylate-based resin cured by UV light, delivered as a liquid in 1 kg bottles with a 2-year shelf life. It is manufactured via additive manufacturing (3D printing) and tested using RXDent-L230 3D printer and RXDent-W90(s) post-cure equipment. The primary difference from the predicate is variation in the specific acrylate resin material composition.

ISO 20795-1 (denture base resin properties), ISO 10993-1 (biocompatibility including cytotoxicity, genotoxicity, sensitization, acute and subchronic toxicity, and irritation), and FDA guidance on Technical Considerations for Additive Manufactured Medical Devices.

The device shares the same product code (EBI), regulation (21 CFR 872.3760), intended use, user population, curing method, material type, and manufacturing approach as the predicate SprintRay High Impact Denture Base. Although the specific acrylate resin formulation differs, comprehensive biocompatibility and mechanical testing demonstrate equivalent performance. Both are methacrylate-based, UV-cured, non-sterile liquids meeting ISO 20795-1 standards, and additive manufacturing testing confirms the resin performs equivalently when printed on permitted machines.