510(k) K011490 ยท KLE Agent, Tooth Bonding, Resin
MODIFICATION TO EXCITE
| Applicant | Ivoclar North America, Inc., Amherst NY, US |
| Decision | Substantially Equivalent, Jun 27, 2001 |
| Received | May 15, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011490
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.