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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 K042658
Device Name PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004
Applicant
NOBEL BIOCARE UAS INC
22715 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887
Applicant Contact ELIZABETH J MASON
Correspondent
NOBEL BIOCARE UAS INC
22715 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887
Correspondent Contact ELIZABETH J MASON
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/28/2004
Decision Date 10/20/2004
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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