Lower riskMedical device recall · FDA · Published October 9, 2020
Talladium Luminesse ML PMMA Milling Blanks: Incorrect Label Risk
Talladium recalls Luminesse ML PMMA milling blanks with incorrect labels that may cause compatibility issues when used with dental milling machines. Affected units have Part no. 4302-B1 (95x20mm) but labeled as 5336-B1 (98x20mm).
Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary crowns and bridge restorations has incorrect label. label states Part no. 5336-B1 (98x20mm). However, the item inside the box was Part no. 4302-B1 (95x20mm). An incorrect label may result in compatibility issues when setting up the disc with milling machine fixtures due to size variation.
Take action
Contact the company
📍Recalling firmTalladium Inc27360 Muirfield Ln · Valencia, CA 91355-1010
✎ GovInfoNow plain-language explainer
Talladium recalls Luminesse ML PMMA milling blanks that have the wrong label. This could cause problems when setting up the blank with dental milling machines because the actual size differs from what's labeled. If you use these blanks, you might have issues making temporary dental crowns or bridges. Read more at govinfonow.com/recall/64103-talladium-luminesse-ml-pmma-milling-blanks-incorrect-label-risk.
“Talladium Luminesse ML PMMA Milling Blanks: Incorrect Label Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64103-talladium-luminesse-ml-pmma-milling-blanks-incorrect-label-risk. Based on FDA recall #Z-0512-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0512-2021%22&limit=1).
The FDA announced on Oct. 9, 2020, that Talladium Inc recalled Luminesse ML PMMA milling blanks due to incorrect labeling that may cause compatibility issues with milling machines. The agency classified the recall as Class III.
How to tell if you have it
Brand: Talladium
Product: Luminesse ML PMMA, 98x20mm, REF: 5336-B1
Lot No.: 1BKI
Quantity: 10 units
The hazard
The heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary crowns and bridge restorations has an incorrect label. The label states Part no. 5336-B1 (98x20mm), but the item inside the box was Part no. 4302-B1 (95x20mm). An incorrect label may result in compatibility issues when setting up the disc with milling machine fixtures due to size variation.
Context
GovInfoNow's records show Talladium Inc has one other recall on record since Aug. 6, 2020. On Aug. 6, 2020, Talladium recalled Luminesse Zirconia Discs due to an incorrect shrinkage label risk.
How to tell if you have this one
Check if your Luminesse ML PMMA blank has a label stating Part no. 5336-B1 (98x20mm) but is actually Part no. 4302-B1 (95x20mm). Affected units were sold with Lot No. 1BKI.
Brand
Talladium
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Label
Verify the part number on the label matches the actual product (Part no. 4302-B1 for 95x20mm).
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide distribution including in the states of PA, KS, OR, FL, CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Kansas, Oregon, Pennsylvania.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0512-2021 (October 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0512-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.