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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name implant, endosseous, root-form
510(k) Number K200867
Device Name Implantswiss Dental Implant System and Implantswiss Dental Abutment System
Applicant
Novodent SA
Y-PARC Technopole Avenue des Sciences 11
Yverdons-les-Bains,  CH CH1400
Applicant Contact Cem Kocer
Correspondent
CardioMed Device Consultants, LLC
1783 Forest Drive #254
Annapolis,  MD  21401
Correspondent Contact H. Semih Oktay
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received04/01/2020
Decision Date 04/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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