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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 K063341
Device Name 3I OSSEOTITE CERTAIN DENTAL IMPLANTS
Applicant
IMPLANT INNOVATIONS, INC.
4555 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Applicant Contact JACQUELYN A HUGHES
Correspondent
IMPLANT INNOVATIONS, INC.
4555 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Correspondent Contact JACQUELYN A HUGHES
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/06/2006
Decision Date 04/30/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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