510(k) K083400 ยท OBR Mouthguard, Over-The-Counter
CUSTOM COMFORT NIGHTGUARD
| Applicant | Den Tek Oral Care, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Dec 11, 2008 |
| Received | Nov 17, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083400
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.