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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 K233231
Device Name Dental Implants and Abutments
Applicant
Ditron Dental, Ltd.
2 Haofe St. Southern Industrial Zone
Ashkelon,  IL 7878002
Applicant Contact Ariel Zuhovitzky
Correspondent
Ditron Dental, Ltd.
M.P Upper Galilee
Ramot-Naftali,  IL 1383000
Correspondent Contact Tali Hazan
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received09/28/2023
Decision Date 04/30/2024
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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