Denture Base

Denture Base is a light-curable methacrylate-based resin used to fabricate and repair removable denture bases in dental laboratories, including full and partial dentures, immediate dentures, and baseplates. It can also be used for try-in dentures and as an aid in bonding denture teeth to the denture base. The device is used with a 3D printer and curing light equipment to manufacture dental prosthetics.

The subject device is a liquid, light-curable, methacrylate-based resin cured with UV light using additive manufacturing technology. It has an 18-month shelf life, is non-sterile, and packaged in a bottle. Physical properties conform to ISO 20795-1 Type 4 material specifications, with substantially equivalent properties to predicate devices in strength, modulus, translucency, and biocompatibility.

ISO 20795-1 (physical properties for denture base resins), ISO 7405 (biocompatibility of dental materials), ISO 10993 (biological evaluation of medical devices), and FDA guidance on Technical Considerations for Additive Manufactured Medical Devices. Testing included homogeneity, surface characteristics, flexural strength, biocompatibility assays, and 3D printing parameter verification.

The subject device demonstrates substantial equivalence through identical indications for use, same product code (EBI), same regulatory classification (21 CFR 872.3760), and substantially equivalent technological characteristics including composition, curing method, physical form, and manufacturing technology. Non-clinical testing per ISO standards shows equivalent physical and biocompatibility properties to both primary (K220042) and secondary (K221678) predicates, with no novel chemical compositions or safety concerns.