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U.S. Department of Health and Human Services

Class 2 Device Recall Dentin/Enamel Etch

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  Class 2 Device Recall Dentin/Enamel Etch see related information
Date Initiated by Firm September 28, 2017
Create Date February 27, 2018
Recall Status1 Terminated 3 on October 05, 2020
Recall Number Z-0741-2018
Recall Event ID 78479
510(K)Number K052501  
Product Classification Agent, tooth bonding, resin - Product Code KLE
Product Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes.

Used for etching enamel and dentin.
Code Information SKU #663-103, Lot No. 164222A, Exp. Date 10/31/2019
Recalling Firm/
Manufacturer		 Cosmedent, Inc.
4646 N Ravenswood Ave
Chicago IL 60640-4510
For Additional Information Contact Gary Chuven
312-644-9365
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KLE and Original Applicant = COSMEDENT, INC.
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