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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
3Shape A/S
Holmens Kanal 7
Copenhagen,  DK DK-1060
Applicant Contact Hanne Nielsen
3Shape A/S
Holmens Kanal 7
Copenhagen,  DK DK-1060
Correspondent Contact Hanne Nielsen
Regulation Number872.5470
Classification Product Code
Subsequent Product Code
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