510(k) K012528 ยท EBF Material, Tooth Shade, Resin
ICE
| Applicant | Southern Dental Industries, Ltd., Bensenville IL, US |
| Decision | Substantially Equivalent, Oct 22, 2001 |
| Received | Aug 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012528
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.