Talladium Inc

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
7
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0512-2021Class IIILuminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabricationOctober 9, 2020
Z-2943-2020Class IITalladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, MAugust 6, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K152023Luminesse Shaded Zirconia SZSeptember 15, 2016
K152066Luminesse Anterior Zirconia ATOctober 21, 2015
K143090LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUIDJune 15, 2015
K142371Luminesse PMMAApril 24, 2015
K140848LUMINESSE PORCELAIN SYSTEMDecember 17, 2014
K100232LUMINESSE ZR BLANKSMay 21, 2010
K894085TALLADIUM TILITE CERAMIC ALLOYDecember 20, 1989