FDA.reportPublic FDA data

CGI

Primary DI
00817477025487
Brand
CGI
Company
CERAGROUP INDUSTRIES INC.
Model
COIVTS
Device description
Opal Incisal Violet 30g
Published
2020-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817477025487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817477025487008174770254878174770254870817477025487

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
016010476
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817477026361CGITSTDS2025-04-04
00817477026378CGITSTBKS2025-04-04
00817477026385CGITSTBRS2025-04-04
00817477026392CGITSTBUS2025-04-04
00817477026408CGITSTGNS2025-04-04
00817477026415CGITSTGYS2025-04-04
00817477026422CGITSTOCS2025-04-04
00817477026439CGITSTVTS2025-04-04
00817477026446CGITSTYLS2025-04-04
00817477026453CGITSTPKS2025-04-04
00817477020048CGITSTPGM52025-04-03
00817477020284CGITSTORS2025-04-03
00817477020291CrystalCeramCCZDBL42025-04-03
00817477020307CrystalCeramCCZECL2025-04-03
00817477020314CrystalCeramCCZOETL2025-04-03
00817477020338CrystalCeramCCZDA22025-04-03
00817477020345CrystalCeramCCZEBU2025-04-03
00817477020352CrystalCeramCCZODA22025-04-03
00817477020369CrystalCeramCCZELT2025-04-03
00817477020376CrystalCeramCCZD352025-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941382296862Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296916Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296923Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296930Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296947Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296954Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296961Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
08800118648406RazorU&C International Co.,LtdEIH2026-09-04
08800118648413RazorU&C International Co.,LtdEIH2026-09-04
08800118648420RazorU&C International Co.,LtdEIH2026-09-04
08800118648437RazorU&C International Co.,LtdEIH2026-09-04
08800118648444RazorU&C International Co.,LtdEIH2026-09-04
08800118648451RazorU&C International Co.,LtdEIH2026-09-04
08800118648468RazorU&C International Co.,LtdEIH2026-09-04
08800118648475RazorU&C International Co.,LtdEIH2026-09-04
08800118648482RazorU&C International Co.,LtdEIH2026-09-04
08800118648499RazorU&C International Co.,LtdEIH2026-09-04
08800118648505RazorU&C International Co.,LtdEIH2026-09-04
08800118648512RazorU&C International Co.,LtdEIH2026-09-04
08800118648529RazorU&C International Co.,LtdEIH2026-09-04
08800118648536RazorU&C International Co.,LtdEIH2026-09-04
08800118648543RazorU&C International Co.,LtdEIH2026-09-04
08800118648550RazorU&C International Co.,LtdEIH2026-09-04
08800118648567RazorU&C International Co.,LtdEIH2026-09-04
08800118648574RazorU&C International Co.,LtdEIH2026-09-04
08800118648581RazorU&C International Co.,LtdEIH2026-09-04
08800118648598RazorU&C International Co.,LtdEIH2026-09-04
08800118648604RazorU&C International Co.,LtdEIH2026-09-04
08800118648611RazorU&C International Co.,LtdEIH2026-09-04
08800118648628RazorU&C International Co.,LtdEIH2026-09-04