openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 1
Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-ceramic (no metal) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks.
The linear shrinkage on the zirconia blank disc s part label is incorrect. The average linear shrinkage found on the product label was outside the acceptable range. The acceptable average linear shrinkage ranges between 1.225 to 1.275. The production lot being recalled has a linear shrinkage rate of 2.251 which is above the acceptable range.
Code information
Lot Number.: 1AZG
Distribution pattern
U.S. Nationwide distribution including in the states of CA, FL, KS, LA, MO, and PA. No OUS Consignees.
