510(k) K012180 ยท EBF Material, Tooth Shade, Resin
A-WEAR
| Applicant | Bisco, Inc., Schaumburg IL, US |
| Decision | Substantially Equivalent, Sep 5, 2001 |
| Received | Jul 12, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012180
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.