Clearance Summary
EXCEL HIGH SPEED DENTAL HANDPIECE received FDA 510(k) clearance under submission number K061581, sponsored by Orthosource, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2006-08-16.
- Submission: K061581
- Applicant / Sponsor: Orthosource, Inc.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2006-08-16
Classification & Regulation
This clearance is catalogued under FDA product code EFA and 21 CFR 872.4200, within the Dental review panel as a Class I device.