510(k) K231793 ยท MQC Mouthguard, Prescription
RODIN 3D Resin SPLINT, Hard/Flex
| Applicant | Belport Company, Inc., Gingi-Pak, Camarillo CA, US |
| Decision | Substantially Equivalent, Mar 26, 2024 |
| Received | Jun 20, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231793
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.