E-CUBE


Device Classification Name

handpiece, direct drive, ac-powered

510(k) Number K111616
Device Name E-CUBE
Applicant
SAESHIN PRECISION CO., LTD.
#93-15, paho-dong, dalseo-gu
daegu, 

KR

704-220

Applicant Contact y s lee
Regulation Number 872.4200
Classification Product Code
EKX  
Date Received 06/10/2011
Decision Date 08/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No