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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 K160060
Device Name DMi Dental Implant System
Applicant
Dmi Innovative Medical Technology , Ltd.
84 Sokolov St.,
Holon,  IL 58330
Applicant Contact Yaniv Haim Buchacho
Correspondent
Duet Medical Consulting , Ltd.
10 Haanafa St., P.O. Box 536
Zur Moshe,  IL 42810
Correspondent Contact Eilat Ezra
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received01/12/2016
Decision Date 10/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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