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 | Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. These products are used by Dental professionals for bonding needs in restorative dental procedures. |
| Product | Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etch… |
| Quantity | 172 kits (4 syringes per kit) |
| Distribution | Worldwide Distribution. |
| Initiated | 2012-05-24 |
| Classified | 2012-06-18 |
| Terminated | 2012-08-15 |
| Recall number | Z-1822-2012 |
| 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-1822-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62120/
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