Clearance Summary
PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE received FDA 510(k) clearance under submission number K080220, sponsored by Italia Medica S.R.L.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2008-07-28.
- Submission: K080220
- Applicant / Sponsor: Italia Medica S.R.L.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4120
- Decision date: 2008-07-28
Classification & Regulation
This clearance is catalogued under FDA product code DZI and 21 CFR 872.4120, within the Dental review panel as a Class II device.