510(k) K091660 ยท OBR Mouthguard, Over-The-Counter
CUSTOM COMFORT NIGHTGUARD VERSION 2
| Applicant | Den Tek Oral Care, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Jun 12, 2009 |
| Received | Jun 9, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091660
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.