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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 K120954
Device Name NOBELPROCERA PEEK ABUTMENTS
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 Received03/30/2012
Decision Date 06/05/2013
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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