510(k) K112397 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
ORTHO-JET CRYSTAL
| Applicant | Lang Dental Mfg. Co., Inc., Wheeling IL, US |
| Decision | Substantially Equivalent, Nov 4, 2011 |
| Received | Aug 19, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112397
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.