Clearance Summary
Smooth Drive contra angle and straight handpieces received FDA 510(k) clearance under submission number K220874, sponsored by Lares Research. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2022-11-07.
- Submission: K220874
- Applicant / Sponsor: Lares Research
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2022-11-07
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.