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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K063403
Device Name CONICAL ANGLED ABUTMENT
Applicant
IMPLANT INNOVATIONS, INC.
4555 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Applicant Contact TAMARA NELSON
Correspondent
IMPLANT INNOVATIONS, INC.
4555 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Correspondent Contact TAMARA NELSON
Regulation Number872.3630
Classification Product Code
NHA  
Date Received11/09/2006
Decision Date 03/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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