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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 K171634
Device Name Ortho System
Applicant
3Shape A/S
Holmens Kanal 7
Copenhagen,  DK 1060
Applicant Contact Antje Marquardsen
Correspondent
3Shape A/S
Holmens Kanal 7
Copenhagen,  DK 1060
Correspondent Contact Antje Marquardsen
Regulation Number872.5470
Classification Product Code
PNN  
Date Received06/02/2017
Decision Date 01/17/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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