Clearance Summary
BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO received FDA 510(k) clearance under submission number K081550, sponsored by Bonart Co., 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 2008-08-28.
- Submission: K081550
- Applicant / Sponsor: Bonart Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4850
- Decision date: 2008-08-28
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.