510(k) K012882 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060
| Applicant | Thermoelastic Technologies, Inc., Appollo Beach FL, US |
| Decision | Substantially Equivalent, Nov 14, 2001 |
| Received | Aug 28, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012882
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.