Clearance Summary
COLGATE ODONTOSON ULTRASONIC SCALER received FDA 510(k) clearance under submission number K921893, sponsored by Perio-Giene. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1993-07-08.
- Submission: K921893
- Applicant / Sponsor: Perio-Giene
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4850
- Decision date: 1993-07-08
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.