510(k) K180344 ยท EJK Liner, Cavity, Calcium Hydroxide
TheraCal DC
| Applicant | Bisco, Inc., Schaumburg IL, US |
| Decision | Substantially Equivalent, Apr 5, 2018 |
| Received | Feb 8, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180344
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.