Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
FDA Recall Z-0741-2018 · Posted None
Recalling FirmCosmedent, Inc.
Recall StatusTerminated
Product CodeKLE
Date Initiated2017-09-28
Date Terminated2020-10-05
Product Quantity84 units
Reason for Recall
Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
Firm Action
Customers were sent recall notification letters on approximately 09/28/2017. The letter identified the affected device and discussed the reason for the recall. Instructions included discontinuing use of the product, and returning it to Cosmedent. The firm will issue a credit or refund for the recalled device.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.