Z-0741-2018Class II

Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for...

Name: Z-0741-2018 Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for...
Creator: Cosmedent, Inc.
Published: 2017-09-28
License: https://open.fda.gov/license/

Cosmedent, Inc. / initiated 2017-09-28 / Terminated / root cause: packaging

FDA source

Cosmedent, Inc. began a recall of Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin on 2017-09-28. FDA classified it as Class II and gives the reason as "Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0741-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-28
Posted: 2018-02-27
Terminated: 2020-10-05
Recalling firm: Cosmedent, Inc.
Product: Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
Product code: KLE Agent, Tooth Bonding, Resin
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.
Root cause tag: packaging
FDA root cause: Under Investigation by 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.
Quantity in commerce: 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.
Product codes and lots: SKU #663-103, Lot No. 164222A, Exp. Date 10/31/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0741-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0741-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27

Product code KLE

K052501Class IIMultiple Resin Tooth Bonding AgentCosmedent, Inc. / cleared 2005-10-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)