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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K173326
Device Name MIS CONNECT Conical Connection Abutment
MIS Implants Technologies LTD.
P.O. Box 7 Bar Lev Industrial Park
Bar Lev Industrial Park,  IL 2015600
Applicant Contact Noa Ofer
Hogan Lovells US LLP
555 13th St. NW
Washington,  DC  20004
Correspondent Contact Randy Prebula
Regulation Number872.3630
Classification Product Code
Date Received10/20/2017
Decision Date 03/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No