510(k) K063483 ยท MQC Mouthguard, Prescription
DEN TEK NIGHTGUARD
| Applicant | Den Tek Oral Care, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Jan 23, 2007 |
| Received | Nov 17, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063483
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.