SprintRay’s high-filler resin receives FDA clearance, with wear resistance approximately 5 times that of its Ceramic Crown material.

Image source: SprintRay official website

DentalGoodNews｜September 1, 2026, SprintRay, an oral 3D printing technology company, announced that its Midas Restore™ permanent restorative resin received FDA 510(k) clearance (K260661) on April 15, 2026, and was commercially launched simultaneously in the U.S. and EU markets on September 1, 2026. According to the company, the material is specifically developed for the Midas Digital Press, with a filler content exceeding 75% by weight, enabling same-day fabrication of dental crowns, inlays, onlays, and veneers in the clinic.

Midas Restore™ features a glass-ceramic and zirconia-filled formulation. According to laboratory test data disclosed by the company, in ISO 6872 three-ball testing, the material achieved a maximum biaxial flexural strength of 215 MPa with an average of 180 MPa; flexural modulus reached up to 10.5 GPa with an average of 10.0 GPa, which the company states approaches dentin levels; surface hardness exceeded 80 HV. After 5,000 simulated toothbrush abrasion cycles, the surface retained 98% of its initial gloss; additionally, in a 200,000-cycle wear test, its abrasion resistance was approximately 5 times greater than SprintRay's previously launched Ceramic Crown material, with wear performance comparable to milled composite ceramics.

In terms of clinical workflow, Midas Restore™ supports a same-day treatment process from scanning and design to pressing, post-curing, and polishing. According to the company, a single capsule can press multiple restorations, post-curing takes 4 minutes, and the polishing step requires no additional glazing or firing procedures.

According to SprintRay, its Digital Press Stereolithography (DPS) technology uses sealed capsules to press high-viscosity materials into the printing area, designed to address the limitations of traditional light-curing 3D printing in handling resins with high filler ratios. As previously reported by DGN, the company's Apex Flex flexible denture resin had also received FDA Class II certification.