K231793
- 510(k) number
- K231793
- Device name
- RODIN 3D Resin SPLINT, Hard/Flex
- Applicant
- Belport Company, Inc., Gingi-Pak CA · US
- Product code
- MQC — Mouthguard, Prescription
- Decision date
- 2024-03-26
- Date received
- 2023-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K231793
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.