Class II — Premier Dental Products Co
| Recalling firm | Premier Dental Products Company |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The hardness not meeting the material specification and may cause the diamond bur to bend. |
| Product | Premier Solo Diamond - Large Invented Cone; SKU: 807016C. |
| Quantity | 77 units |
| Distribution | US Nationwide distribution in the states of CA, MN, NY, PA, TN, VA, WA. |
| Initiated | 2025-02-27 |
| Classified | 2025-03-21 |
| Recall number | Z-1408-2025 |
| 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 — Premier Dental Products Co (Z-1408-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96394/
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