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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name implant, endosseous, root-form
510(k) Number K073142
Device Name NOBELREPLACE HEXAGONAL IMPLANT
Applicant
NOBEL BIOCARE USA LLC
22715 SAVI RANCH PARKWAY
YORBA LINDA,  CA  92887
Applicant Contact KAM LEUNG
Correspondent
NOBEL BIOCARE USA LLC
22715 SAVI RANCH PARKWAY
YORBA LINDA,  CA  92887
Correspondent Contact KAM LEUNG
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/07/2007
Decision Date 01/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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