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510(k) Data Aggregation
K Number
K181816Device Name
Ceramic Denture Zirconia Ceramics Block
Manufacturer
Date Cleared
2018-11-29
(143 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Qinhuangdao Silide Ceramic Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Ceramic Denture Zirconia Ceramics Block are intended for use with CAD/CAM technology to produce all ceramic dental restorations (full contour crowns, bridges, inlays, and Veneers) as prescribed by a dentist.
Device Description
The Ceramic Denture Zirconia Ceramics Block are derived from zirconia powder that has been processed via uni-aixial die pressing, followed by isostatic pressing, to achieve various shapes of uniform density and distribution. The ceramic blocks can be fabricated into various prosthetic dental devices. The zirconia powder is composed of ZrO2+Y2O3+HfO2+Al2O3. The performance of the Ceramic Denture Zirconia Ceramics Block conforms to ISO 6872:2015 Dentistry: Ceramic Materials.
The Ceramic Denture Zirconia Ceramics Block are offered in four (4) different product families of shapes and a multitude of different sizes and are capable of being machined into complex dental shapes using modern machining methods.
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