Device product
Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
Z-0741-2018
Product summary
- Firm
- Cosmedent, Inc.
- Event
- Event 78479
- Status
- Terminated
- Classification
- Class II
- Quantity
- 84 units
- Official record key
device-enforcement:Z-0741-2018
Official wording
Reason: Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
Code information: SKU #663-103, Lot No. 164222A, Exp. Date 10/31/2019
Distribution pattern: Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain.
Derived failure modes
-
Unknown
Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.