AEU-26L ELCTRONIC ENDODONTIC SYSTEM


Device Classification Name

handpiece, direct drive, ac-powered

510(k) Number K111078
Device Name AEU-26L ELCTRONIC ENDODONTIC SYSTEM
Applicant
ASEPTICO, INC.
8333 216th st., s.e.
woodinville, 
WA 
98072

Applicant Contact grant ramaley
Regulation Number 872.4200
Classification Product Code
EKX  
Date Received 04/18/2011
Decision Date 06/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Abbreviated
Reviewed by Third Party Yes

Combination Product

No