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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 K193352
Device Name AbutmentCAD
Applicant
exocad GmbH
37, Julius-Reiber-Str.
Darmstadt,  DE 64293
Applicant Contact Stefan Walter
Correspondent
exocad GmbH
37, Julius-Reiber-Str.
Darmstadt,  DE 64293
Correspondent Contact Stefan Walter
Regulation Number872.3630
Classification Product Code
PNP  
Date Received12/04/2019
Decision Date 07/21/2021
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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