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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 K061969
Device Name PREFORMANCE POSTS AND TEMPORARY CYLINDERS
Applicant
IMPLANT INNOVATIONS, INC.
4555 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Applicant Contact JIM BANIC
Correspondent
IMPLANT INNOVATIONS, INC.
4555 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Correspondent Contact JIM BANIC
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/12/2006
Decision Date 07/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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