IPS e.max Zirconia

IPS e.max Zirconia is a yttrium-stabilized zirconium oxide material used to fabricate fixed all-ceramic dental restorations such as crowns, bridges, inlays, onlays, and veneers. The material is supplied as pre-sintered discs with incisal, transition, and dentin zones in various shades and thicknesses, plus accompanying color and effect liquids for staining and characterization before final sintering.

IPS e.max Zirconia features zoned disc design (incisal, transition, dentin zones) with different strength properties to enable more esthetic restorations compared to the single-shaded predicate discs. More conservative design parameters were established for the new device. Chemical composition is similar to the predicate but in different quantities. Chemical solubility is 10 µg·cm⁻² (vs. 100 µg·cm⁻² for predicate) due to different ISO 6872 versions; linear thermal expansion is slightly lower but conforms to ISO 6872:2024.

EN ISO 6872:2024 (Dentistry – Ceramic Materials); ISO 10993 (biocompatibility); ISO 7405; ISO 21726:2019; ISO 14971:2019. Device classified as Type II Class 5 under ISO 6872:2024.

Both devices are pre-sintered zirconia discs for fabricating fixed all-ceramic dental restorations via CAD/CAM milling followed by sintering. Although IPS e.max Zirconia supports additional indications (inlays and veneers) and has zoned disc design, these are common features for this device type. Biocompatibility was fully assessed and found substantially equivalent; device performance testing met ISO 6872 criteria. The working principle, material composition, and clinical application are substantially equivalent to the predicate Zenostar devices.