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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 K122602
Device Name NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS
Original Applicant
NOBEL BIOCARE AB
22715 savi ranch pkwy.
yorba linda,  CA  92887
Original Contact phuong nguyen son
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/27/2012
Decision Date 03/13/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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