Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are yttria-stabilized zirconia ceramic materials used to manufacture custom dental restorations such as crowns, bridges, veneers, inlays, and onlays via CAD/CAM milling. The device comes in white and pre-shaded color variants (20 Vita shades) with various translucencies and dimensions for different milling systems.

The proposed device is substantially identical to the predicate in composition (yttria-stabilized zirconia with optional inorganic pigments), form (white and colored blanks), and performance specifications (flexural strength ≥500 MPa for Class 4, ≥800 MPa for Class 5 per ISO 6872). Changes include: added new specifications to existing models, introduction of 11 new models from an alternate zirconia powder supplier, and a claimed 5-year shelf life.

ISO 6872:2024 (Dentistry—Ceramic Materials), ISO 7405:2018 (Biocompatibility), ISO 10993 series (Cytotoxicity, Skin Sensitization, Oral Mucosa Irritation, Acute Systemic Toxicity, Implantation, Chemical Characterization), and ASTM F1980-21 (Accelerated Aging for Shelf Life).

The proposed device has identical intended use, similar indications for use, and the same composition and performance characteristics as the predicate K212765. Models made from the original supplier have unchanged formulation and processing; new models from the alternate supplier meet the same ISO 6872:2024 performance requirements and pass biocompatibility testing. Shape and dimension changes are purely physical and do not affect safety or effectiveness.