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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 K182219
Device Name SGS Dental Implants System
Applicant
Sgs International, Ltd.
Karolyi Istvan St. 1-3
Budapest,  HU H 1047
Applicant Contact Michaeli Shabtai
Correspondent
Sterling Medical Registration
22815 Ventura Blvd.
Woodland Hills,  CA  91364
Correspondent Contact Daniela Levy
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received08/15/2018
Decision Date 08/29/2019
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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