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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 K072642
Device Name BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS
Applicant
BIOMET 3I, INC.
4555 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Applicant Contact DIANA TAYLOR
Correspondent
BIOMET 3I, INC.
4555 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Correspondent Contact DIANA TAYLOR
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/18/2007
Decision Date 12/20/2007
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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