510(k) K983668 ยท KLE Agent, Tooth Bonding, Resin
MODIFICATION OF PQ1
| Applicant | Ultradent Products, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Nov 30, 1998 |
| Received | Oct 19, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983668
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.