510(k) K992292 ยท KLE Agent, Tooth Bonding, Resin
GLUMA COMFORT BOND + DESENSITIZER
| Applicant | Heraeus Kulzer, Inc., South Bend IN, US |
| Decision | Substantially Equivalent, Oct 1, 1999 |
| Received | Jul 7, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992292
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2007 | Heraeus Kulzer Inc., Dental Products Division Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710. Terminated |
KLE | None listed |
| Oct 2, 2007 | 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 Terminated |
KLE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.