FDA 510(k) Application Details - K052885

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K052885
Device Name Abutment, Implant, Dental, Endosseous
Applicant NOBEL BIOCARE USA LLC
22715 SAVI RANCH PARKWAY
YORBA LINDA, CA 92887 US
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Contact HERBERT CRANE
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 10/13/2005
Decision Date 12/23/2005
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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