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510(k) Data Aggregation
K Number
K232438Device Name
Dental Glass Ceramics Blocks
Manufacturer
Date Cleared
2023-12-01
(109 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Aibodent Biotechnology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Dental Glass Ceramics Blocks are indicating all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior 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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