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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
3Shape A/S
Holmens Kanal 7
Copenhagen,  DK 1060
Applicant Contact Jenny Axel
3Shape A/S
Holmens Kanal 7
Copenhagen,  DK 1060
Correspondent Contact Jenny Axel
Regulation Number872.3630
Classification Product Code
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