Prismatik Dentalcraft, Inc. · Class II · Cleared Feb 25, 2025
| K-number | K250223 |
| Device name | BruxZir® Esthetic NOW |
| Applicant | Prismatik Dentalcraft, Inc. |
| Product code | EIH |
| Device class | Class II |
| Decision date | Feb 25, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 872.6660 |
BruxZir® Esthetic NOW is a pre-shaded, fully sintered zirconia CAD/CAM block used for dental restorations, specifically crowns and single-unit restorations. The device is milled using CAD/CAM or manual milling machines by dental laboratories or dental professionals and requires no additional sintering, staining, glazing, or polishing.
The subject device is composed of yttria-stabilized zirconia (YSZ) with pigments, similar to the predicate BruxZir® NOW. Both are fully sintered blocks available in 2 sizes; the key difference is that the subject device is designed only for single-unit restorations (anterior and posterior geometries), whereas the predicate supports both single and multiple-unit restorations. The subject device offers Bleach White, Bleach 1, and 16 VITA Classical shades, while the predicate includes Bleach 3 as well.
ISO 6872:2024 for flexural strength, solubility, coefficient of thermal expansion, and radioactivity testing. ISO 10993-1:2018 for biocompatibility evaluation. ISO 14971:2019 for risk management. ASTM D4169-22 for packaging validation.
The subject device shares the same intended use (fabrication of dental restorations for chewing function), material composition (YSZ with pigments), and design principle (fully sintered block form for CAD/CAM milling) as the predicate. Despite differences in available shades and restriction to single-unit restorations, performance testing demonstrates equivalent flexural strength (>800 MPa), solubility, thermal expansion, and biocompatibility. The pigment differences do not affect safety or effectiveness as verified by biocompatibility testing.
View the full FDA submission: accessdata.fda.gov