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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 K102209
Device Name ENCODE PATIENT SPECIFIC ABUTMENT
Applicant
BIOMET 3I, INC.
4555 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Applicant Contact SIMEON SIMONE
Correspondent
BIOMET 3I, INC.
4555 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Correspondent Contact SIMEON SIMONE
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/05/2010
Decision Date 12/03/2010
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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