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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 K043042
Device Name PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052
Applicant
NOBEL BIOCARE AB
22715 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887
Applicant Contact ELIZABETH J MASON
Correspondent
NOBEL BIOCARE AB
22715 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887
Correspondent Contact ELIZABETH J MASON
Regulation Number872.3630
Classification Product Code
NHA  
Date Received11/04/2004
Decision Date 11/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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