510(k) K192913 ยท KLE Agent, Tooth Bonding, Resin
R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose
| Applicant | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS, Konya, TR |
| Decision | Substantially Equivalent, Jan 19, 2021 |
| Received | Oct 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192913
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.