Recall Z-0036-2008 ยท KLE Agent, Tooth Bonding, Resin
Heraeus Kulzer Inc., Dental Products Division
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
| Date | Oct 2, 2007 (initiated Jul 9, 2007) |
| Status | Terminated |
| Reason | The material may solidify in the bottle, and thus be rendered unusable. |
| Root cause | Process design |
| Action | Consignees were notified via phone or undated letter sent via fax beginning on or about 7/9/07 and instructed to contact the firm for return authorization/instructions. |
| Quantity | 736 |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992292 | GLUMA COMFORT BOND + DESENSITIZER Heraeus Kulzer, Inc., Oct 1, 1999 |