510(k) K801234 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
REIGNING DENTURE MADE OF POLYCARB. RESIN
| Applicant | Oki Shiks USA , Ltd., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 9, 1980 |
| Received | May 27, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801234
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.