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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 K970499
Device Name BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM
Applicant
Nobel Biocare Uas, Inc.
777 Oakmont Lane, Suite 100
Westmont,  IL  60559
Applicant Contact BESTY A BROWN
Correspondent
Nobel Biocare Uas, Inc.
777 Oakmont Lane, Suite 100
Westmont,  IL  60559
Correspondent Contact BESTY A BROWN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received02/10/1997
Decision Date 10/16/1997
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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