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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 K173207
Device Name SIC invent Dental Implant Systems
Applicant
Sic Invent AG
Birmannsgasse 3
Basel,  CH CH-4055
Applicant Contact Cretia Arlene McNett
Correspondent
Sic Invent AG
Birmannsgasse 3
Basel,  CH CH-4055
Correspondent Contact Cretia Arlene McNett
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received10/02/2017
Decision Date 04/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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