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 | Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution. |
| Product | Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment. |
| Quantity | 217 units |
| Distribution | Nationwide Distribution including UT, CA, WA, VA, OH, and TN. |
| Initiated | 2013-11-19 |
| Classified | 2013-12-11 |
| Terminated | 2014-10-06 |
| Recall number | Z-0481-2014 |
| 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-0481-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66978/
Alerts for ULTRADENT PRODUCTS, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.