Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series

Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series are ceramic dental blanks made from zirconia powder (ZrO₂ + Y₂O₃ + HfO₂ ≥ 98%) with inorganic pigments. They are used to fabricate anterior and posterior dental restorations (crowns, veneers, facings, dentures) via CAD/CAM or manual machining at dental laboratories or by dental professionals.

The subject device differs from the predicate in manufacturing process: GT(F) P1 and GT(F) P2 use a six-layer padding process for multi-layer aesthetic effect, while SP series uses no padding for single-layer effect. GT(F) P1 and SP have flexural strength >800 MPA (Type II, Class 5 ceramics per ISO 6872); GT(F) P2 has >500 MPa (Type II, Class 4(a)). All are supplied in various shapes and fifty colors with gradual translucency changes.

ISO 6872 (Dentistry, Ceramic Materials) was used for bench testing to verify specifications including radioactivity, thermal expansion, chemical solubility, and flexural strength. Biocompatibility assessment per ISO standards was also performed.

The subject device and its predicate (K231687) share identical indications for use, basic design (blocks, discs, rods), materials (zirconia composition ≥ 98%), processing (sintering > 1400°C), dimensions, single-use application, fifty colors, and similar flexural strength and translucency effects. Minor manufacturing differences do not raise safety or effectiveness concerns, and performance is essentially equivalent to the predicate.