510(k) K150492 ยท OBR Mouthguard, Over-The-Counter
Ora-GUARD Dental Grind Guard
| Applicant | Bite Tech, Inc., Norwalk CT, US |
| Decision | Substantially Equivalent, Feb 19, 2016 |
| Received | Feb 25, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150492
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.