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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 K140728
Device Name MPI - MOLECULAR PRECISION IMPLANT, CPI - CYLINDRICAL PRECISION IMPLANT, OPI - ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PR
Applicant
Ditron Precision, Ltd.
Haofe 2 St., P.O Box 5010
Netanya,  IL 78150
Applicant Contact TALI HAZAN
Correspondent
Ditron Precision, Ltd.
Ramot Naftali
M.P Upper Galillee
Ramot Naftali,  IL 13830
Correspondent Contact TALI HAZAN
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received03/24/2014
Decision Date 10/17/2014
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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