Clearance Summary
Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) received FDA 510(k) clearance under submission number K162856, sponsored by Bonart Co., Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2017-07-18.
- Submission: K162856
- Applicant / Sponsor: Bonart Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2017-07-18
Classification & Regulation
This clearance is catalogued under FDA product code EGS and 21 CFR 872.4200, within the Dental review panel as a Class I device.