Class II — Ultradent Products, Inc.
| Recalling firm | ULTRADENT PRODUCTS, INC. |
|---|---|
| Registered facility | Ultradent Products Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The barcode label was placed underneath the sterile barrier and the product was re-wrapped. |
| Product | Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins. |
| Quantity | 61 units |
| Distribution | Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution. |
| Initiated | 2017-08-04 |
| Classified | 2017-09-26 |
| Terminated | 2018-01-04 |
| Recall number | Z-3214-2017 |
| 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 — Ultradent Products, Inc. (Z-3214-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77891/
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