E3 TORQUE CONTROL MOTOR


Device Classification Name

controller, foot, handpiece and cord

510(k) Number K103653
Device Name E3 TORQUE CONTROL MOTOR
Applicant
DENTSPLY INTERNATIONAL INC.
221 west philadelphia st.
suite 60
york, 
PA 
17401

Applicant Contact helen lewis
Correspondent
DENTSPLY INTERNATIONAL INC.
221 west philadelphia st.
suite 60
york, 
PA 
17401

Correspodent Contact helen lewis
Regulation Number 872.4200
Classification Product Code
EBW  
Date Received 12/13/2010
Decision Date 05/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No