510(k) K081669 ยท OBR Mouthguard, Over-The-Counter
IMPROVED COMFORT-FIT NIGHTGUARD
| Applicant | Den Tek Oral Care, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Jul 10, 2008 |
| Received | Jun 13, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081669
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.