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510(k) Data Aggregation
K Number
K242407Device Name
Dental Glass Ceramics Blocks (HT, LT, MT)
Manufacturer
Date Cleared
2024-11-13
(91 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Hunan Vsmile Biotechnology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Dental Glass Ceramics Blocks are indicated for fabricating all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, using the hot press technique or CAD/CAM system.
Device Description
Dental Glass Ceramics Blocks are derived from dental porcelain powder that has been processed into their final net shapes. These blanks are then being further fabricated (using hot press or CAD/CAM technologies) into all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns. The ceramics material is composed of SiO2, Li2O, K2O, Al2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface.
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