Multi M Series

The Multi M Series is a zirconia-based ceramic material used to manufacture dental prosthesis cores and restorations. It is provided in various shapes and shades (278 total) and is processed using CAD/CAM milling machines to create all-ceramic crowns. The device is classified as ISO 6872 Type 2 Class 5 and is available in W-type and Z-type configurations to accommodate different CAD/CAM machine jigs.

Both the subject device and predicate (Zmaxx T series) are zirconia-based ceramics with identical coefficient of thermal expansion (10.6±0.5×10⁻⁶K⁻¹) and similar material composition. The subject device has higher flexural strength (>800 MPa vs >600 MPa) and improved chemical solubility (<100 µg/cm² vs <2000 µg/cm²). The primary difference is that the subject device offers significantly more shade options (278 vs 3 colors) and uses updated ISO 6872:2015 mechanical testing standards versus the predicate's 2008 version.

ISO 6872:2015 (appearance, dimensions, packaging, uniformity, extraneous materials, flexural strength, thermal expansion, chemical solubility, radioactivity), ISO 13356 (monoclinic phase fraction and flexural strength after accelerated aging), and ISO 10993-3, 5, 6, 10, 11, and 33 (biocompatibility testing).

The subject device is substantially equivalent because it shares the same intended use (dental prosthesis manufacture), identical principles of operation (block installation on milling machine with CAD/CAM processing), and equivalent material composition and physical properties as the predicate. Although raw material mixing ratios differ, performance testing per ISO 6872 demonstrates the subject device meets or exceeds the predicate's specifications in critical properties (flexural strength and chemical solubility), establishing functional equivalence despite compositional variations.