Asiga DentaBASE

Asiga DentaBASE is a 3D printer resin used exclusively for professional dental work to manufacture 3D printed denture bases. The denture bases produced are suitable for dental indications including removable dentures. It is a Type 4 light-cure methacrylate-based resin supplied as a pre-mixed material in natural pink color, non-sterile.

DentaBASE is a Type 4 light-cure methacrylate-based resin with photoinitiator, UV absorber, dispersant and pigments, designed for use with DLP-based 3D printers. Both subject and predicate devices differ in material formulation and have different bonding agents for teeth assembly and different shelf lives, though both rely on the same equipment type (scanner, design software, DLP-based 3D printer) and post-curing unit.

ISO 20795-1 for Type 4 materials; ISO 10993-1 and ISO 7405 for biocompatibility; ASTM D4169-22/14-576 for packaging and shelf life validation; FDA Guidance on Denture Base Resins – Performance Criteria for Safety and Performance Based Pathway (April 13, 2022).

DentaBASE and the predicate NextDent Denture 3D+ are both 3D print resin materials for manufacturing denture bases with identical indications for use and no differences in classification, regulation number, product code, prescription status, or sterility status. Both devices underwent equivalent performance testing per FDA denture base resin guidance and ISO 20795-1, demonstrating equivalent bench test results (flexural strength, modulus, water sorption, solubility, residual monomer, biocompatibility). Material formulation and shelf life differences do not raise new safety or effectiveness questions, as testing confirmed performance equivalence to the predicate.