Luminesse Multilayer Anterior Zirconia A 19820-ATML-A1

GUDID D79119820ATMLA10

TALLADIUM, INC.

Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic
Primary Device IDD79119820ATMLA10
NIH Device Record Key6bd4ce2e-4eb7-4395-8d3d-dd0212de0785
Commercial Distribution StatusIn Commercial Distribution
Brand NameLuminesse Multilayer Anterior Zirconia A
Version Model Number19820-ATML-A1
Catalog Number19820-ATML-A1
Company DUNS094430642
Company NameTALLADIUM, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD79119820ATMLA10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPowder, Porcelain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-18
Device Publish Date2019-01-17

Devices Manufactured by TALLADIUM, INC.

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D79119518OFA0 - Luminesse Zirconia Discs2023-04-05 95 x 18 mm
D79119530OFA0 - Luminesse Zirconia Discs2023-04-05 95 x 30
D79110005 - Tilite Ceramic Alloys - Premium2022-12-07 5 oz of Tilite (Premium)
D79110105 - Tilite Ceramic Alloys - Vita2022-12-07 5 oz of Tilite (Vita)
D79110205 - Tilite Ceramic Alloys - Star2022-12-07 5 oz of Tilite (Star)
D79111105 - Tilite Ceramic Alloys - Omega2022-12-07 5 oz. of Tilite (Omega)
D791CLOFADG0 - Color Liquid2022-11-25 Dark Gray (Color)

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