Clearance Summary
Dental Electrical Motor iRoot Pro received FDA 510(k) clearance under submission number K191276, sponsored by Changzhou Bomedent Medical Technology 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 2020-06-30.
- Submission: K191276
- Applicant / Sponsor: Changzhou Bomedent Medical Technology Co.,Ltd
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2020-06-30
Classification & Regulation
This clearance is catalogued under FDA product code EKX and 21 CFR 872.4200, within the Dental review panel as a Class I device.