510(k) K161891 ยท KLE Agent, Tooth Bonding, Resin
HC Primer
| Applicant | Shofu Dental Corporation, San Marcos CA, US |
| Decision | Substantially Equivalent, Nov 21, 2016 |
| Received | Jul 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161891
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.