510(k) K950860 ยท KLE Agent, Tooth Bonding, Resin
PERMALUTE
| Applicant | Ultradent Products, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Mar 23, 1995 |
| Received | Feb 27, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950860
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.