FDA 510(k) Application Details - K073142

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K073142
Device Name Implant, Endosseous, Root-Form
Applicant NOBEL BIOCARE USA LLC
22715 SAVI RANCH PARKWAY
YORBA LINDA, CA 92887 US
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Contact KAM LEUNG
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 11/07/2007
Decision Date 01/11/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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