Clearance Summary
CST61 HIGH SPEED TURBINE HANDPIECE received FDA 510(k) clearance under submission number K063110, sponsored by Shanghai Dental Instrument Factory. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2006-10-26.
- Submission: K063110
- Applicant / Sponsor: Shanghai Dental Instrument Factory
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2006-10-26
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.