Search Results
Found 3 results
510(k) Data Aggregation
K Number
K232682Device Name
Pre-Sintered Zirconia Coloring Liquid
Manufacturer
Chengdu Besmile Medical Technology Co., Ltd.
Date Cleared
2024-03-19
(200 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Chengdu Besmile Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is only used for coloring Zirconia Dental Ceramics of our company to achieve clinical aesthetic restoration.
Device Description
Pre-Sintered Zirconia Coloring Liquid is mainly divided into 16 colors, 26 colors and special colors. The product is mainly composed of purified water(55%~95%), ferric chloride (0~9%), Erbium Chloride(0~17%), polyethylene glycol(2%~6%),Polydextrose(0.5%~8%),Gluconic acid(1%~2%),Citric acid(0%~1%) and Yttrium chloride(0~12%).
Ask a Question
K Number
K232673Device Name
Dental Glass Ceramics
Manufacturer
Chengdu Besmile Medical Technology Co., Ltd.
Date Cleared
2024-01-23
(144 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Chengdu Besmile Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dental Glass Ceramics are indicated for fabrications such as veneers, inlay/ onlay/ onlay/ partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.
Device Description
This product is composed of SiO2 , Al2O3 , Li2O , K2O , Na2O , CeO2 , Pr6O11 , ZrO2 , P2O5 , СаО , МпО2 , Ег2Оз .
Ask a Question
K Number
K232676Device Name
Dental Porcelain Powder
Manufacturer
Chengdu Besmile Medical Technology Co., Ltd.
Date Cleared
2024-01-23
(144 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Chengdu Besmile Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is indicated for use as a veneering material for fixed prosthesis in crowns, bridges.
Device Description
This product includes Porcelain Powder, Stain/Glaze and Blending liquid. The porcelain powder is composed of silica (SiOz), alumina (AlzOs), potassium oxide (K2O), sodium oxide (Na2O), boron trioxide (B2O3), calcium oxide (CaO), barium oxide (BaO), zirconia (ZrO2), zinc oxide (ZnO) , lithium oxide (Li₂O), tin oxide (SnO₂), magnesium oxide (MgO), Yttrium oxide (Y2O3) and terbium oxide (Tb2Os).. The blending liquid is composed of purified water, 1, 3-butanediol and diethanolamine. The Stain/Glaze is composed of the porcelain powder and the blending liquid in accordance with the mass ratio of 1:1.
Ask a Question
Page 1 of 1