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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 K151455
FOIA Releasable 510(k) K151455
Device Name 3Shape Abutment Designer Software
3Shape A/S
Holemens Kanal 7
Copenhagen,  DK 1060
Applicant Contact Hanne Nielsen
3Shape A/S
Holemens Kanal 7
Copenhagen,  DK 1060
Correspondent Contact Hanne Nielsen
Regulation Number872.3630
Classification Product Code
Date Received06/01/2015
Decision Date 09/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No