| K-number | K252446 |
| Device name | BruxZir® NOW |
| Applicant | Prismatik Dentalcraft, Inc. |
| Product code | EIH |
| Device class | Class II |
| Decision date | Sep 3, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 872.6660 |
BruxZir® NOW is a pre-shaded, fully sintered zirconia CAD/CAM block used to fabricate single-unit and multiple-unit dental restorations through milling machines in dental laboratories or by dental professionals. The device is available in multiple shades and two sizes, with a contraindication limiting bridge block designs to a maximum of four units with a maximum of two pontics between pillars.
The subject device is identical to the predicate in design, material composition (yttria-stabilized zirconia with colorant pigments), available shades, and block sizes. Both are fully sintered blocks offered in two sizes for single and multiple-unit restorations. The only difference is the addition of a contraindication for bridge block use; no physical components or material composition changed.
ISO 6872:2024 (flexural strength, solubility, radioactivity testing for dental ceramics), ISO 10993-1:2018 (biocompatibility), and ASTM D4169-16 (packaging validation).
The device is substantially equivalent because no physical components, materials, manufacturing methods, or fundamental technology differ from the predicate BruxZir® NOW (K220816). The only change is a labeling addition of a contraindication based on risk assessment regarding bridge design limitations imposed by block size. Since all performance specifications and safety data remain unchanged from the predicate, and the contraindication does not address new safety risks but merely clarifies proper use, the device presents no new safety or effectiveness concerns.
View the full FDA submission: accessdata.fda.gov