510(k) K161077 ยท KLE Agent, Tooth Bonding, Resin
RnD TE and RnD SE
| Applicant | Apex Dental Materials, Inc., Lake Zurich IL, US |
| Decision | Substantially Equivalent, Mar 17, 2017 |
| Received | Apr 18, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161077
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.