Z-0512-2021Class III

Luminesse ML PMMA, 98x20mm, REF: 5336-B1 -

Name: Z-0512-2021 Luminesse ML PMMA, 98x20mm, REF: 5336-B1 -
Creator: Talladium Inc
Published: 2020-10-09
License: https://open.fda.gov/license/

Talladium Inc / initiated 2020-10-09 / Terminated / root cause: labeling and UDI

FDA source

Talladium Inc began a recall of Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crowns and bridges. All blanks are solely... on 2020-10-09. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0512-2021
Classification: Class III
Status: Terminated
Initiated: 2020-10-09
Posted: 2020-12-01
Terminated: 2022-08-17
Recalling firm: Talladium Inc
Product: Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crowns and bridges. All blanks are solely used by a Trained Dental Technician or on the order of a dental professional.
Product code: EBG Crown And Bridge, Temporary, Resin
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On 10/09/20, Urgent Medical Device Recall notices were mailed and/or emailed to customers. Customers were asked to do the following: 1) Check your stock and quarantine the affected stock on hand to prevent further use. 2) Using the provided customer letter and Recall Acknowledgement Form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3) Return product, complete the enclosed Recall Acknowledgement Form, scan and email to [email protected] Complete the attached Acknowledgement form even if you do not have any affected stock, scan and email. The following contact information was provided: 800-221-6449 and www.TALLADIUM.com
Quantity in commerce: 10
Distribution: U.S. Nationwide distribution including in the states of PA, KS, OR, FL, CA.
Product codes and lots: Lot No. 1BKI

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0512-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0512-2021	Class III	Terminated	Voluntary: Firm initiated	2020-12-09	2020-12-01

Product code EBG

K142371Class IILuminesse PMMATalladium, Inc. / cleared 2015-04-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)