Clearance Summary
SCALETRON PIEZO ULTRASOUND SCALER received FDA 510(k) clearance under submission number K033120, sponsored by Pac-Dent International (Suzhou), Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2004-01-29.
- Submission: K033120
- Applicant / Sponsor: Pac-Dent International (Suzhou), Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4850
- Decision date: 2004-01-29
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.