Prismatik Dentalcraft, Inc. · Class II · Cleared Jan 30, 2026
| K-number | K254283 |
| Device name | BruxZir® Shaded 16 PLUS |
| Applicant | Prismatik Dentalcraft, Inc. |
| Product code | EIH |
| Device class | Class II |
| Decision date | Jan 30, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 872.6660 |
BruxZir® Shaded 16 PLUS is a zirconia milling block used by dental technicians to create custom all-ceramic dental restorations (crowns and bridges) for both front and back teeth. The material is milled using CAD/CAM technology, then sintered at high temperature to achieve final strength and color without requiring additional staining steps.
The subject device uses yttria-stabilized zirconia with integrated colorants, offered in multiple sizes and thicknesses, and employs a press manufacturing process instead of the predicate's colloidal slip-casting process. The subject device achieves final VITA shades without additional post-sintering coloring, whereas the predicate requires staining and glazing after sintering. Both devices share the same flexural strength (>800 MPa), thermal expansion, chemical solubility, and biocompatibility profiles.
ISO 6872:2024 (flexural strength, thermal expansion, chemical solubility, radioactivity), ISO 10993-1:2025 and ISO 10993-5:2009 (biocompatibility), and ASTM D4169-23e1 (packaging validation).
The subject device is substantially equivalent to predicate K130924 (BruxZir® Shaded) because both share identical intended use, indications for use, fundamental design principles (CAD/CAM-based design and high-temperature sintering), and material composition (yttria-stabilized zirconia). Performance testing confirmed equivalent mechanical and biocompatibility properties, and the manufacturing process change and enhanced pre-sintered shade selection do not raise new safety or effectiveness concerns.
View the full FDA submission: accessdata.fda.gov