510(k) K123849 ยท OBR Mouthguard, Over-The-Counter
NEW COMFORT-FIT DENTAL GUARD
| Applicant | Den Tek Oral Care, Inc., Maryville TN, US |
| Decision | Substantially Equivalent, Jan 10, 2013 |
| Received | Dec 14, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123849
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.