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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 K180968
Device Name AlphaDent Implants Dental Implants System
Applicant
Alphadent Implants, Ltd.
Carl-Zeiss-Str 4
Leonberg-Gebershein,  DE 71229
Applicant Contact Natalia Kenig
Correspondent
Qualitech Top , Ltd.
P.O. Box 12082
Nahariya,  IL 2201202
Correspondent Contact Simha Sibony
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/13/2018
Decision Date 07/03/2019
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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