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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 K083100
Device Name GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP
Applicant
NOBEL BIOCARE USA, LLC
22715 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887
Applicant Contact HERBERT CRANE
Correspondent
NOBEL BIOCARE USA, LLC
22715 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887
Correspondent Contact HERBERT CRANE
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
DZE  
Date Received10/20/2008
Decision Date 11/19/2008
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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