Clearance Summary
RODIN Palette Naturalizing Kit received FDA 510(k) clearance under submission number K223365, 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 2023-03-27.
- Submission: K223365
- Applicant / Sponsor: Belport Company, Inc., Gingi-Pak
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3310
- Decision date: 2023-03-27
Classification & Regulation
This clearance is catalogued under FDA product code EBD and 21 CFR 872.3310, within the Dental review panel as a Class II device.