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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 K132125
Device Name A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEM
Applicant
A.B. Dental Devices , Ltd.
22817 Ventura Blvd.
#161
Woodland Hills,  CA  91364
Applicant Contact DANIELA LEVY
Correspondent
A.B. Dental Devices , Ltd.
22817 Ventura Blvd.
#161
Woodland Hills,  CA  91364
Correspondent Contact DANIELA LEVY
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received07/10/2013
Decision Date 01/21/2014
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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