510(k) K000189 ยท KLE Agent, Tooth Bonding, Resin
PQ1
| Applicant | Ultradent Products, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, May 11, 2000 |
| Received | Jan 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000189
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.