Clearance Summary
VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES received FDA 510(k) clearance under submission number K112305, sponsored by Thunder Tiger Corp.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2012-04-17.
- Submission: K112305
- Applicant / Sponsor: Thunder Tiger Corp.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2012-04-17
Classification & Regulation
This clearance is catalogued under FDA product code EGS and 21 CFR 872.4200, within the Dental review panel as a Class I device.