FDA.reportPublic FDA data

Luminesse Zirconia Discs

Primary DI
D7916849A10
Brand
Luminesse Zirconia Discs
Company
TALLADIUM, INC.
Model
6849-A1
Catalog number
6849-A1
Published
2019-01-17
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
D7916849A10PrimaryHIBCC0

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
D79119514OFA0Luminesse Zirconia Discs19514-OFA19514-OFA2018-11-20
D79119516OFA0Luminesse Zirconia Discs19516-OFA19516-OFA2018-11-25
D79119520OFA0Luminesse Zirconia Discs19520-OFA19520-OFA2019-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06976581410009Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410016Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410023Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410030Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410047Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410054Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410061Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410078Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
EDDI963011DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963051DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963061DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963071DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963081DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963091DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963161DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963171DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963431DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963441DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963451DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963821DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963831DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963841DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963851DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963861DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963941DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963951DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963961DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963971DD cubeY® HLDental Direkt GmbHEIH2026-06-02
D800FMAA01030Colour Liquid A1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA04030Colour Liquid A3,5 (20 ml)ZIRKONZAHN SRLEIH2026-05-28