Clearance Summary
STATIS DENTAL HANDPIECES received FDA 510(k) clearance under submission number K071891, sponsored by Scican , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2007-09-13.
- Submission: K071891
- Applicant / Sponsor: Scican , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2007-09-13
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.