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 | Terminated |
| Reason | Complaints were received claiming the material failed to polymerize under the curing light. After investigation, it was determined that a wrong photo-initiator was used in the production batch U30755 of Helioseal Clear. This failure can lead to incomplete curing of the sealant, if mono-wave LED curing lights are used. |
| Product | Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant |
| Quantity | Domestic: 406 units |
| Distribution | Nationwide distribution including NY, PA, FL, IN, IA, TX, and CA. |
| Initiated | 2016-02-12 |
| Classified | 2016-02-29 |
| Terminated | 2017-05-08 |
| Recall number | Z-1026-2016 |
| 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-1026-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73308/
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