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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 K022562
Device Name VARIOUS BRANEMARK SYSTEM IMPLANTS-IMMEDIATE FUNCTION INDICATION
Applicant
Nobel Biocare AB
22725 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Applicant Contact KATHLEEN DRAGOVICH
Correspondent
Nobel Biocare AB
22725 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Correspondent Contact KATHLEEN DRAGOVICH
Regulation Number872.3640
Classification Product Code
DZE  
Date Received08/02/2002
Decision Date 10/11/2002
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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