510(k) K113326 ยท OBR Mouthguard, Over-The-Counter
ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD
| Applicant | Oralabs, Inc., Parker CO, US |
| Decision | Substantially Equivalent, Jun 27, 2012 |
| Received | Nov 10, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113326
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.