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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 K081128
Device Name MOLAR IMPLANT
Applicant
Nobel Biocare AB
22715 Savi Ranch Pkwy.
Yorba Linda,,  CA  92887
Applicant Contact THUONG NGUYEN SON
Correspondent
Nobel Biocare AB
22715 Savi Ranch Pkwy.
Yorba Linda,,  CA  92887
Correspondent Contact THUONG NGUYEN SON
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/21/2008
Decision Date 11/07/2008
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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