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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 K233252
Device Name Straumann CARES Visual and Nova Dental CAD
Applicant
Institut Straumann AG
Peter Merian Weg 12
Basel,  CH CH-4002
Applicant Contact Gordon Dodds
Correspondent
Straumann USA, LLC
6 0 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Jennifer M Jackson
Regulation Number872.3630
Classification Product Code
PNP  
Date Received09/28/2023
Decision Date 12/26/2024
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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