K231793 is an FDA 510(k) clearance for the RODIN 3D Resin SPLINT, Hard/Flex. This device is classified as a Mouthguard, Prescription.
Submitted by Belport Company, Inc., Gingi-Pak (Camarillo, US). The FDA issued a Cleared decision on March 26, 2024, 280 days after receiving the submission on June 20, 2023.
This device falls under the Dental FDA review panel.
| 510(k) Number | K231793 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2023 |
| Decision Date | March 26, 2024 |
| Days to Decision | 280 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | MQC - Mouthguard, Prescription |
| Device Class | - |