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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 K182228
Device Name MIS LOCKiT Abutments System, OT-Equators and Ball Attachments
Applicant
MIS Implants Technologies Ltd.
P.O. Box 7, Bar Lev Industrial Park
Bar Lev Industrial Park,  IL 2015600
Applicant Contact Arbel Shezaf
Correspondent
MIS Implants Technologies Ltd.
P.O. Box 7, Bar Lev Industrial Park
Bar Lev Industrial Park,  IL 2015600
Correspondent Contact Arbel Shezaf
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/16/2018
Decision Date 01/28/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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