Recall Z-2128-2014— Novocol, Inc.

Name: FDA recall Z-2128-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-16

Class II · Terminated

Class II FDA medical device recall by Novocol, Inc., initiated 2014-07-16, terminated 2014-12-31. It names one FDA 510(k) clearance: K042614. Product: Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.. Reason: Septodont is recalling Self-Etch bond because the material was incorrectly packaged..

Recalling firm: Novocol, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-07-16
Terminated: 2014-12-31
Firm location: Louisville, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K042614 — S&C-SELF ETCH PR-BONDS & C Polymer GmbH·cleared 2004-11-22

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

Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.

Reason for recall

Septodont is recalling Self-Etch bond because the material was incorrectly packaged.

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