510(k) K812116 ยท KLE Agent, Tooth Bonding, Resin
PERMAGUM
| Applicant | Espe-Premier Sales Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 31, 1981 |
| Received | Jul 27, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812116
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.