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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 K061477
Device Name MULTI-UNIT ABUTMENTS FOR ASTRATECH, CAMLOG AND ANKYLOS IMPLANT SYSTEMS
Applicant
Nobel Biocare AB
22715 Savi Ranch Pkwy.
Yorba Linda,,  CA  92887
Applicant Contact PHUONG NGUYEN SON
Correspondent
Nobel Biocare AB
22715 Savi Ranch Pkwy.
Yorba Linda,,  CA  92887
Correspondent Contact PHUONG NGUYEN SON
Regulation Number872.3630
Classification Product Code
NHA  
Date Received05/30/2006
Decision Date 08/11/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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