Recall Z-0741-2018— Cosmedent, Inc.

Name: FDA recall Z-0741-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-28

Class II · Terminated

Class II FDA medical device recall by Cosmedent, Inc., initiated 2017-09-28, terminated 2020-10-05. It names one FDA 510(k) clearance: K052501. Product: Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.. Reason: Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material..

Recalling firm: Cosmedent, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-09-28
Terminated: 2020-10-05
Firm location: Chicago, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K052501 — MULTIPLE RESIN TOOTH BONDING AGENTCosmedent, Inc.·cleared 2005-10-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.