VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES


Device Classification Name

handpiece, contra- and right-angle attachment, dental

510(k) Number K112305
Device Name VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES
Applicant
THUNDER TIGER CORP.
no. 7, 6th road
industry park
taichung, 

TW

40755

Applicant Contact jo lee
Correspondent
THUNDER TIGER CORP.
no. 7, 6th road
industry park
taichung, 

TW

40755

Correspodent Contact jo lee
Regulation Number 872.4200
Classification Product Code
EGS  
Date Received 08/11/2011
Decision Date 04/17/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No