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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 K062566
Device Name NOBELREPLACE TAPERED CONICAL CONNECTION
Applicant
NOBEL BIOCARE USA LLC
22715 SAVI RANCH PARKWAY
YORBA LINDA,  CA  92887
Applicant Contact HERBERT CRANE
Correspondent
NOBEL BIOCARE USA LLC
22715 SAVI RANCH PARKWAY
YORBA LINDA,  CA  92887
Correspondent Contact HERBERT CRANE
Regulation Number872.3640
Classification Product Code
DZE  
Date Received08/31/2006
Decision Date 12/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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