MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM


Device Classification Name

handpiece, direct drive, ac-powered

510(k) Number K110753
Device Name MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM
Applicant
DENTSPLY INTERNATIONAL, INC.
221 west philadelphia st.
suite 60
york, 
PA 
17404

Applicant Contact helen lewis
Correspondent
DENTSPLY INTERNATIONAL, INC.
221 west philadelphia st.
suite 60
york, 
PA 
17404

Correspodent Contact helen lewis
Regulation Number 872.4200
Classification Product Code
EKX  
Date Received 03/18/2011
Decision Date 06/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No