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510(k) Data Aggregation
K Number
K230259Device Name
Soreal Press, Soreal CAD
Manufacturer
Date Cleared
2023-05-25
(114 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen UP3d Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Soreal Press is indicated for single-unit anterior or posterior prostheses and for three-unit prostheses, such as veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique. Soreal CAD is indicated for single-unit anterior or posterior prostheses and for three-unit prostheses, such as veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns, using the CAD/CAM system.
Device Description
Our products are divided into Soreal Press and Soreal CAD. Soreal Press is put into the porcelain casting furnace and form it by hot pressing at 915-930 °C, and treatment by sandblasting and glazing. Soreal CAD is cut by grinding equipment with wet processing, and put into the porcelain casting furnace at 840-850°C for 30 min to secondary crystallization treatment. Then dye it. They are all composed of SiO2, Li2O, K2O, P2O5, Al2O3 and other oxides. They have a variety of colors, and users can choose the right color to match the patient's natural teeth. In general, our products are also called Dental glass ceramic.
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