Recall Z-2129-2014— Novocol, Inc.
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: Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restorations. Package contains 100 0.125 mL unit dose tips, 100 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 recordK-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
Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restorations. Package contains 100 0.125 mL unit dose tips, 100 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.