Clearance Summary
ULTRASONIC SURGICAL UNIT received FDA 510(k) clearance under submission number K110881, sponsored by Dong IL Technology , 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 2011-12-16.
- Submission: K110881
- Applicant / Sponsor: Dong IL Technology , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4120
- Decision date: 2011-12-16
Classification & Regulation
This clearance is catalogued under FDA product code DZI and 21 CFR 872.4120, within the Dental review panel as a Class II device.