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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 K072917
Device Name JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM
Applicant
Odontit S.A.
Marcelo T De Alvear 2099
3 Deg A-C1122aae
Buenos Aires,  AR
Applicant Contact MARIO GERSBERG
Correspondent
Odontit S.A.
Marcelo T De Alvear 2099
3 Deg A-C1122aae
Buenos Aires,  AR
Correspondent Contact MARIO GERSBERG
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
OAT  
Date Received10/12/2007
Decision Date 01/14/2008
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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