Tilite Ceramic Alloys - Vita

GUDID D79110105

5 oz of Tilite (Vita)

TALLADIUM, INC.

Dental casting non-noble alloy
Primary Device IDD79110105
NIH Device Record Key472e4ec0-739f-4f22-a610-ab74c70cba16
Commercial Distribution StatusIn Commercial Distribution
Brand NameTilite Ceramic Alloys - Vita
Version Model Number101-5
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 Batchfalse
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
HIBCCD79110105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EJHAlloy, Metal, Base

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-07
Device Publish Date2022-11-29

Devices Manufactured by TALLADIUM, INC.

D79119510OFA0 - Luminesse Zirconia Discs2023-04-05 95 x 10 mm
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 - Vita2022-12-075 oz of Tilite (Vita)
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)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.