Clearance Summary
ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191 received FDA 510(k) clearance under submission number K090749, sponsored by Villa Sistemi Medicali S.P.A.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-05-18.
- Submission: K090749
- Applicant / Sponsor: Villa Sistemi Medicali S.P.A.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2009-05-18
Classification & Regulation
This clearance is catalogued under FDA product code EHD and 21 CFR 872.1800, within the Dental review panel as a Class II device.