ENDO-EXPRESS (R) HANDPIECE


Device Classification Name

handpiece, contra- and right-angle attachment, dental

510(k) Number K111541
Device Name ENDO-EXPRESS (R) HANDPIECE
Applicant
ESSENTIAL DENTAL SYSTEMS, INC.
89 leuning street
suite 8
south hackensack, 
NJ 
07606

Applicant Contact jeffrey wan
Correspondent
ESSENTIAL DENTAL SYSTEMS, INC.
89 leuning street
suite 8
south hackensack, 
NJ 
07606

Correspodent Contact jeffrey wan
Regulation Number 872.4200
Classification Product Code
EGS  
Date Received 06/02/2011
Decision Date 03/16/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No