Clearance Summary
tün® ultrasonic tips product family received FDA 510(k) clearance under submission number K182145, sponsored by Engineered Endodontics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2019-06-07.
- Submission: K182145
- Applicant / Sponsor: Engineered Endodontics
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4850
- Decision date: 2019-06-07
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.