FDA-Device2018-03-07Class II
Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
Cosmedent, Inc.
Hazard
Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
Sold states
Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain.
Affected count
84 units
Manufactured in
4646 N Ravenswood Ave, N/A, Chicago, IL, United States
Products
Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0741-2018Don't want to check this manually?
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