510(k) K003293 ยท KLE Agent, Tooth Bonding, Resin
EXCITE DSC
| Applicant | Ivoclar North America, Inc., Amherst NY, US |
| Decision | Substantially Equivalent, Feb 6, 2001 |
| Received | Oct 20, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003293
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.