I-ENDO DUAL


Device Classification Name

controller, foot, handpiece and cord

510(k) Number K111623
Device Name I-ENDO DUAL
Applicant
SATELEC-ACTEON GROUP
124 gaither drive , suite 140
mt laurel, 
NJ 
08054

Applicant Contact rick rosati
Correspondent
SATELEC-ACTEON GROUP
124 gaither drive , suite 140
mt laurel, 
NJ 
08054

Correspodent Contact rick rosati
Regulation Number 872.4200
Classification Product Code
EBW  
Date Received 06/10/2011
Decision Date 01/10/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No