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510(k) Data Aggregation
K Number
K241316Device Name
Zirconia Block
Manufacturer
Date Cleared
2024-07-09
(60 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Hunan Hualian Special Ceramics Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HT, HT-C, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML: used to make the crown, bridge, inlay, veneer of the all-porcelain restoration.
UT, UT-C, UT-ML and 3D-PRO: used to make the crown, maximum 3-unit bridge, inlay, veneer of the all-porcelain restoration.
Device Description
Zirconia Block is used for dental restorations, such as crown, bridge, inlay, veneer, using CAD/CAM or manual milling machines. The main ingredients of the product include zirconia, yttrium oxide, hafnium oxide, alumina and other oxides. Through the digital scanning of the tooth or tooth mold, the three-dimensional data of the tooth mold is obtained. According to the CAD design is carried out to design the porcelain block processing model. Then CNC machine tool was used to make CAM according to the porcelain block processing model, and the inner crown of all-porcelain denture was made by air sintering or vacuum sintering, so as to achieve the strength and aesthetic effect required by clinical use. Finally, the inner crown of the all-porcelain denture was glazed with porcelain powder to form the combination of porcelain, and the all-porcelain denture was made.
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