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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 K191443
Device Name MSDI Dental Implants System
Applicant
Medical Systems and Devices International Ltd.
Ba'alei Hamalaha 26
haifa,  IL 3223020
Applicant Contact iman khorshid
Correspondent
QRS
Industrial Park Tefen
tefen,  IL 2495900
Correspondent Contact iman khorshid
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received05/30/2019
Decision Date 06/26/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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