EnvisionTEC’s E-Denture material for the Perfactory family of 3D printers is an FDA-approved, biocompatible Class IIa material suitable for printing all types of denture bases. This material has low shrinkage compared to standard PMMA denture base materials, which results in excellent fitting denture bases. This 3D-printed solution allows for a natural looking appliance with exceptional customized fit.
EnvisionTEC’s E-Denture and E-Dent materials have been approved by the FDA through its 510(k) clearance process as a denture and temporary restoration material.
More information can be found at the links below:
https://www.accessdata.fda.gov/cdrh_docs/pdf16/k162572.pdf
https://www.accessdata.fda.gov/cdrh_docs/pdf10/K102776.pdf