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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 K913404
Device Name IMPLANDRILL - THREADED DENTAL IMPLANT
Applicant
Impladrill , Ltd.
C/O Bar-Ziv Engineering/Consul
16 Shivat-Zion St.
Kfar-Sava 44286 Israel,  IL
Applicant Contact BAR-ZIV
Correspondent
Impladrill , Ltd.
C/O Bar-Ziv Engineering/Consul
16 Shivat-Zion St.
Kfar-Sava 44286 Israel,  IL
Correspondent Contact BAR-ZIV
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/30/1991
Decision Date 03/31/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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