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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Teeth, Porcelain
510(k) Number K032562
Device Name PROCEARA COPINGS AND PONTIC
Applicant
Nobel Biocare AB
22725 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Applicant Contact ELIZABETH J MASON
Correspondent
Nobel Biocare AB
22725 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Correspondent Contact ELIZABETH J MASON
Regulation Number872.3920
Classification Product Code
ELL  
Date Received08/20/2003
Decision Date 02/06/2004
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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