Class II — Cosmedent, Inc.
| Recalling firm | COSMEDENT, INC. |
|---|---|
| Registered facility | COSMEDENT, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material. |
| Product | Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin. |
| Quantity | 84 units |
| Distribution | Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain. |
| Initiated | 2017-09-28 |
| Classified | 2018-02-27 |
| Terminated | 2020-10-05 |
| Recall number | Z-0741-2018 |
| 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 — Cosmedent, Inc. (Z-0741-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78479/
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