Clearance Summary
MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK received FDA 510(k) clearance under submission number K033630, sponsored by Rhein 83 Srl. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2004-04-21.
- Submission: K033630
- Applicant / Sponsor: Rhein 83 Srl
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2004-04-21
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.