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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 K072980
Device Name NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS
Applicant
NOBEL BIOCARE AB
22715 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887
Applicant Contact KAM LEUNG
Correspondent
NOBEL BIOCARE AB
22715 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887
Correspondent Contact KAM LEUNG
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received10/23/2007
Decision Date 12/20/2007
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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