FDA 510(k) Application Details - K122602

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K122602
Device Name Abutment, Implant, Dental, Endosseous
Applicant NOBEL BIOCARE AB
22715 SAVI RANCH PKWY.
YORBA LINDA, CA 92887 US
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Contact PHUONG NGUYEN SON
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 08/27/2012
Decision Date 03/13/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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