Class II — Ivoclar Vivadent, Inc.
| Recalling firm | IVOCLAR VIVADENT |
|---|---|
| Registered facility | View this company's 11 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected. |
| Product | Article No. NA6050411, Valiant PhD No. 1 Econo |
| Quantity | 2 boxes (500 per box) |
| Distribution | US Nationwide distribution in the states IN and TN. |
| Initiated | 2023-12-21 |
| Classified | 2024-02-07 |
| Recall number | Z-1006-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ivoclar Vivadent, Inc. (Z-1006-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93796/
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