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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthodontic Software
510(k) Number K152086
Device Name 3Shape Ortho System
Applicant
3Shape A/S
Holmens Kanal 7
Copenhagen,  DK Dk-1060
Applicant Contact Hanne Nielsen
Correspondent
3Shape A/S
Holmens Kanal 7
Copenhagen,  DK Dk-1060
Correspondent Contact Hanne Nielsen
Regulation Number872.5470
Classification Product Code
PNN  
Subsequent Product Code
LLZ  
Date Received07/27/2015
Decision Date 04/28/2016
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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