510(k) K083479 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
BIOCRYL X
| Applicant | Great Lakes Orthodontics, Ltd., Tonawanda NY, US |
| Decision | Substantially Equivalent, Feb 27, 2009 |
| Received | Nov 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083479
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.