Clearance Summary
PRODRIVE SYSTEMS REPLACEMENT TURBINE received FDA 510(k) clearance under submission number K062219, sponsored by Prodrive Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2006-08-04.
- Submission: K062219
- Applicant / Sponsor: Prodrive Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2006-08-04
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.