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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K150490
Device Name UnicLine Mobile
Applicant
Heka Dental A/S
Balsershoj 38
Dk-2635 Ishoj,  DK
Applicant Contact Claus van der Goot
Correspondent
Third Party Review Group, LLC
45 Rockefeller Plz., Suite 2000
New York,  NY  10111
Correspondent Contact DAVE YUNGVIRT
Regulation Number872.6640
Classification Product Code
EIA  
Date Received02/25/2015
Decision Date 04/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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