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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 K200188
Device Name DSI Dental Implant System
Applicant
DSI Dental Solutions Ltd
59 haAvoda St Light Industrial Zone
Ashdod,  IL 7706300
Applicant Contact Shlomi Krasner
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 Received01/24/2020
Decision Date 04/01/2020
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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