FDA.reportPublic FDA data

Luminesse Multi-Layer PMMA Discs

Primary DI
D7914303A10
Brand
Luminesse Multi-Layer PMMA Discs
Company
TALLADIUM, INC.
Model
4303A1
Published
2016-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142371000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142371000Luminesse PMMATalladium, Inc.2015-04-24EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7914303A10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymer-based dental model materialA variety of dental materials dedicated for modelling and for use during production of dental restorations. It is based on various kinds of polymers. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
094430642
Device count
1

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
E235DD16A1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A2ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A35MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A3MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B3MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL3ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL4MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BLML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BLMN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16C1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16C1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16C2ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16C2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16D2ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16D2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16D3MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
00371347023398Advance Dental ProductsThe Atlanta Dental Supply CompanyEBG2026-07-08
00371347023404Advance Dental ProductsThe Atlanta Dental Supply CompanyEBG2026-07-08
00371347023411Advance Dental ProductsThe Atlanta Dental Supply CompanyEBG2026-07-08
EPOLPMFLAG5600PMMA CAD/CAM discPOLIDENT d.o.o.EBG2025-05-13
EPOLPMMA0230PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0310PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0390PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07