FDA.reportPublic FDA data

Luminesse Zirconia Discs

Primary DI
D79119514OFA0
Brand
Luminesse Zirconia Discs
Company
TALLADIUM, INC.
Model
19514-OFA
Catalog number
19514-OFA
Published
2018-11-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100232000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100232000LUMINESSE ZR BLANKSTalladium, Inc.2010-05-21EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D79119514OFA0PrimaryHIBCC0

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
094430642
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D79119510OFA0Luminesse Zirconia Discs19510-OFA2023-03-28
D79119518OFA0Luminesse Zirconia Discs19518-OFA19518-OFA2023-03-28
D79119530OFA0Luminesse Zirconia Discs19530-OFA19530-OFA2023-03-28
D791CLOFADG0Color Liquid252302022-11-17
D791CLOFADP0Color Liquid252332022-11-17
D791CLOFALG0Color Liquid252292022-11-17
D791CLOFALP0Color Liquid252312022-11-17
D791CLOFAMP0Color Liquid252322022-11-17
D791CLOFAA10OFA Coloring LiquidCL-OFA-A1CL-OFA-A12019-02-21
D791CLOFAKIT0OFA Coloring LiquidCL-OFA-KITCL-OFA-KIT2019-02-20
5144B3Luminesse Zirconia Discs5144B42017-02-12
D7911904GL0Luminesse Low Fusing Glaze Liquid1904GL2016-10-24
D7911904ML0Luminesse Low Fusing Modeling Liquid1904ML2016-10-24
D7911904MLL0Luminesse Low Fusing Modeling Liquid 1 Liter1904MLL2016-10-24
D7911904MLM0Luminesse Low Fusing Modeling Liquid 250 ml Bottle1904MLM2016-10-24
D7911904OL0Luminesse Low Fusing Opaque Liquid1904OL2016-10-24
D79119512OFA0Luminesse Zirconia Discs19512-OFA19512-OFA2019-01-16
D79119516OFA0Luminesse Zirconia Discs19516-OFA19516-OFA2018-11-25
D79119520OFA0Luminesse Zirconia Discs19520-OFA19520-OFA2019-01-16
D79119525OFA0Luminesse Zirconia Discs19525-OFA19525-OFA2019-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800121750769Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
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08800121750837Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750844Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750875Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750882Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121750899Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751117Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751124Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751131Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751148Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751193Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751209Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751254Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751261Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751278Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751285Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751339Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751346Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751353Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751360Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751377Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751384Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751803Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751810Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751827Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751834Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751889Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27
08800121751896Estar-ZOsstem Implant Co.,Ltd.EIH2024-08-27