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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 K190406
Device Name SDS2.2 dental implant
Applicant
Sds Swiss Dental Solutions AG
Konstanzerstrasse 11
Kreuzlingen,  CH 8280
Applicant Contact Martin Chares
Correspondent
Sds Swiss Dental Solutions AG
Konstanzerstrasse 11
Kreuzlingen,  CH 8280
Correspondent Contact Martin Chares
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received02/21/2019
Decision Date 02/20/2020
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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