Clearance Summary
PROULTRA PIEZO ULTRASONIC received FDA 510(k) clearance under submission number K113430, sponsored by Satelec - Acteon Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2012-02-23.
- Submission: K113430
- Applicant / Sponsor: Satelec - Acteon Group
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4850
- Decision date: 2012-02-23
Classification & Regulation
This clearance is catalogued under FDA product code ELC and 21 CFR 872.4850, within the Dental review panel as a Class II device.