Class III — 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 III |
| Status | Terminated |
| Reason | Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring. |
| Product | Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502 |
| Quantity | 3,255 units |
| Distribution | US and Canada |
| Initiated | 2017-08-03 |
| Classified | 2018-02-21 |
| Terminated | 2018-08-28 |
| Recall number | Z-0666-2018 |
| 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 III recall — Ivoclar Vivadent, Inc. (Z-0666-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79064/
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