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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dental Abutment Design Software For Dental Laboratory
510(k) Number K200100
Device Name Abutment Design
Applicant
3Shape A/S
Holmens Kanal 7
Copenhagen,  DK 1060
Applicant Contact Jenny Axel
Correspondent
3Shape A/S
Holmens Kanal 7
Copenhagen,  DK 1060
Correspondent Contact Jenny Axel
Regulation Number872.3630
Classification Product Code
PNP  
Date Received01/16/2020
Decision Date 10/07/2020
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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