510(k) K112445 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
SOFRELINER TOUGH S
| Applicant | Tokuyama Dental Corporation, Washington DC, US |
| Decision | Substantially Equivalent, Oct 28, 2011 |
| Received | Aug 24, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112445
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.