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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 St., Suite 8
South Hackensack,  NJ  07606
Applicant Contact JEFFREY WAN
Correspondent
Essential Dental Systems, Inc.
89 Leuning St., Suite 8
South Hackensack,  NJ  07606
Correspondent Contact JEFFREY WAN
Regulation Number872.4200
Classification Product Code
EGS  
Date Received06/02/2011
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
Predetermined Change
Control Plan Authorized		 No
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