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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 K033724
Device Name NOBEL BIOCARE CENTRIC POST, MODELS 31234, 31235 AND 31236
Applicant
Nobel Biocare Uas, Inc.
22715 Savi Ranch Pkwy.
Yorba Linda,,  CA  92887
Applicant Contact ELIZABETH J MASON
Correspondent
Nobel Biocare Uas, Inc.
22715 Savi Ranch Pkwy.
Yorba Linda,,  CA  92887
Correspondent Contact ELIZABETH J MASON
Regulation Number872.3630
Classification Product Code
NHA  
Date Received11/26/2003
Decision Date 02/23/2004
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
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