Class II — Sybron Dental Specialties
| Recalling firm | SYBRON DENTAL SPECIALTIES, INC. |
|---|---|
| Registered facility | View this company's 17 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination. |
| Product | Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single Patient Use Fits 13mm Tips. Pack of 400. Metrex Research, Manufacturer. Inner individual packaging of each sleeve: Cure Sleeve by Pinnacle Model 4500 |
| Quantity | 172 |
| Distribution | Worldwide distribution. US Nationwide, Canada, Australia, Netherlands, Switzerland, Japan, |
| Initiated | 2015-02-11 |
| Classified | 2015-03-18 |
| Terminated | 2015-05-21 |
| Recall number | Z-1291-2015 |
| 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 — Sybron Dental Specialties (Z-1291-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70551/
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