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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 K071370
Device Name NOBELACTIVE INTERNAL CONNECTION IMPLANT
Applicant
NOBEL BIOCARE AB
22715 SAVI RANCH PARKWAY
YORBA LINDA,  CA  92887
Applicant Contact PHUONG NGUYEN SON
Correspondent
NOBEL BIOCARE AB
22715 SAVI RANCH PARKWAY
YORBA LINDA,  CA  92887
Correspondent Contact PHUONG NGUYEN SON
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received05/16/2007
Decision Date 08/03/2007
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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