Clearance Summary
WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head received FDA 510(k) clearance under submission number K160410, sponsored by Dental Savings Club. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2016-09-29.
- Submission: K160410
- Applicant / Sponsor: Dental Savings Club
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2016-09-29
Classification & Regulation
This clearance is catalogued under FDA product code EFB and 21 CFR 872.4200, within the Dental review panel as a Class I device.