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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 K112259
Device Name NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS
Applicant
NOBEL BIOCARE AB
22715 SAVI RANCH PARKWAY
YORBA LINDA,  CA  92887
Applicant Contact HERBERT CRANE
Correspondent
NOBEL BIOCARE AB
22715 SAVI RANCH PARKWAY
YORBA LINDA,  CA  92887
Correspondent Contact HERBERT CRANE
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/08/2011
Decision Date 10/28/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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