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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 K181266
Device Name Implantswiss Dental Implant System, Implantswiss Dental Abutment System
Applicant
Novodent SA
Y-Parc Technopole Ave. Des Sciences 11
Yverdons-Les-Bains,  CH CH1400
Applicant Contact Cem Kocer
Correspondent
CardioMed Device Consultants, LLC
1783 Forest Dr. # 254
Annapolis,  MD  21401
Correspondent Contact H. Semih Oktay
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received05/14/2018
Decision Date 11/01/2018
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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