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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 K052951
Device Name ENDOPORE ANATOMIC ENDOSSEOUS DENTAL IMPLANT SYSTEM
Applicant
Innova Life Sciences Corp.
555 13th St. NW
Washington,  DC  20004
Applicant Contact HOWARD HOLSTEIN
Correspondent
Innova Life Sciences Corp.
555 13th St. NW
Washington,  DC  20004
Correspondent Contact HOWARD HOLSTEIN
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received10/20/2005
Decision Date 01/27/2006
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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