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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 K191911
Device Name 3Shape Splint Design
Applicant
3Shape A/S
Copenhagen,  DK 1060
Applicant Contact Shreyosi Chakraborty
Correspondent
3Shape A/S
Copenhagen,  DK 1060
Correspondent Contact Shreyosi Chakraborty
Regulation Number872.5470
Classification Product Code
PNN  
Date Received07/17/2019
Decision Date 11/27/2019
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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