510(k) K110037 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID
| Applicant | Heraeus Kulzer, LLC, South Bend IN, US |
| Decision | Substantially Equivalent, Apr 29, 2011 |
| Received | Jan 6, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110037
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.