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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
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