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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 K182615
Device Name Surgikor Dental Implant System
Applicant
Surgikor, LLC
1299 W Jefferson Blvd.
Los Angeles,  CA  90007
Applicant Contact Jeremy Barbanell
Correspondent
Blackwell Device Consulting
P.O. Box 718
Gresham,,  OR  97030 -0172
Correspondent Contact Angela Blackwell
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received09/21/2018
Decision Date 07/08/2019
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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