Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported December 9, 2020
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.
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Talladium Inc recalled Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the … - a low-severity action.
Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the … was recalled by Talladium Inc in December 9, 2020. Reason: Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary crowns and br…. Check the official notice for the remedy. Verify recall #Z-0512-2021 with the FDA Devices before acting.
The recall
Talladium Inc issued this low-severity FDA Devices recall-Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary crowns and br….
- Low
- severity level
- 10 units
- affected scope
- Class III
- classification
- December 9, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0512-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0512-2021) was formally reported on December 9, 2020, with the manufacturer initiating the action on October 9, 2020. It is classified under Low severity (Class III), with a current status of Terminated. Talladium Inc is listed as the recalling firm, operating out of Valencia, CA. Federal records list the affected scope as 10.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: U.S. Nationwide distribution including in the states of PA, KS, OR, FL, CA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
10
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0512-2021 |
| Date reported | December 9, 2020 |
| Date initiated | October 9, 2020 |
| Recalling firm | Talladium Inc |
| Firm location | Valencia, CA |
| Affected scope | 10 |
| Distribution | U.S. Nationwide distribution including in the states of PA, KS, OR, FL, CA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0512-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Talladium Inc. Units affected: 10.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 9, 2020. Severity: Low. Recall number: Z-0512-2021.
Where was the recalled product distributed? ▼
Distribution: U.S. Nationwide distribution including in the states of PA, KS, OR, FL, CA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0512-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 9, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.