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510(k) Data Aggregation
(29 days)
The device is indicated for fabrication of anterior and posterior dental restorations using different CAD/CAM or manual machines. All blanks are processed through dental laboratories or by dental professionals.
"Gradual Dental Zirconia Blank- GT(F) P1, GT(F) P2, and SP Series" are derived from zirconia powder that has been processed through various molding and sintering techniques - into their final net shapes. These blanks are then further fabricated into various prosthetic dental devices intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. The zirconia powder is composed of ZrO₂+ Y₂ O₃ + HfO₂+ Fe₂O₃+ Er₂O₃. The performance of formed zirconia dental blanks conforms to ISO 6872, Dentistry, Ceramic Materials.
"Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series" are ceramic dental blanks designed for the manufacture of ceramic dental prosthetic devices. The dental prosthetic devices are fabricated by CAD/CAM machining processes. All prosthetic dental devices are intended for single use applications. At the dental lab, the blanks are held to the CAD/CAM machine which is used to machine to the final dental restoration. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO₂ so that its final properties can be achieved.
"Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series" are different from the predicate device as they have different manufacture process. GT(F) P1 and GT(F) P2 series use six-layer padding process to produce multi-layer aesthetic effect, while the SP series does not use padding process, produce single aesthetic effect.
GT(F) P1 and SP series have Flexural Strength of >800 MPA, They belong to Type II, Class 5 ceramics per ISO 6872.
GT(F) P2 series have Flexural Strength of >500 MPa, They belong to Type II, Class 4(a) ceramics per ISO 6872.
"Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series" are supplied in different shapes, such as blocks, discs, rods, or customer ordered shapes. It is also supplied in the combinations of fifty different colors.
The different colors are originated from the different constituent of color additives (such as Fe₂O₃, Er₂O₃); the different translucencies are originated from small difference in the amount of Y₂ O₃, and the multilayer aesthetic effect is originated from the different padding method used in the process of dry pressing.
The GT(F) P1 and GT(F) P2 series are supplied in gradual changing translucencies, and multi-layer aesthetic effect. The SP series are supplied with no gradual changing translucencies, and in single-layer aesthetic effect.
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