Class III — Ultradent Products, Inc.
| Recalling firm | ULTRADENT PRODUCTS, INC. |
|---|---|
| Registered facility | Ultradent Products Inc. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Orthodontic brackets distributed was incorrectly labeled. |
| Product | Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets. |
| Quantity | 124 |
| Distribution | USA Nationwide Distribution including the states of CA, AZ, CO and WA. |
| Initiated | 2013-02-08 |
| Classified | 2013-02-22 |
| Terminated | 2013-06-07 |
| Recall number | Z-0876-2013 |
| 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 III recall — Ultradent Products, Inc. (Z-0876-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64303/
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