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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 K080864
Device Name CAM STRUCTSURE PRECISION MILLED BARS
Applicant
BIOMET 3I, INC.
4555 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Applicant Contact TAMARA WEST
Correspondent
BIOMET 3I, INC.
4555 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Correspondent Contact TAMARA WEST
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/28/2008
Decision Date 07/21/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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