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 | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. |
| Product | Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain |
| Quantity | 27 units |
| Distribution | US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI. |
| Initiated | 2016-05-27 |
| Classified | 2016-10-04 |
| Terminated | 2018-06-14 |
| Recall number | Z-0028-2017 |
| 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-0028-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74320/
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