510(k) K013997 ยท KLE Agent, Tooth Bonding, Resin
UNIFIL BOND
| Applicant | GC America, Inc., Alsip IL, US |
| Decision | Substantially Equivalent, Feb 20, 2002 |
| Received | Dec 4, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013997
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.