Clearance Summary
RODIN Titan 3D Resin received FDA 510(k) clearance under submission number K240688, sponsored by Belport Company, Inc., Gingi-Pak. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2024-06-20.
- Submission: K240688
- Applicant / Sponsor: Belport Company, Inc., Gingi-Pak
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3760
- Decision date: 2024-06-20
Classification & Regulation
This clearance is catalogued under FDA product code EBI and 21 CFR 872.3760, within the Dental review panel as a Class II device.