FDA 510(k) Application Details - K031568

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K031568
Device Name Implant, Endosseous, Root-Form
Applicant BICON, INC.
501 ARBORWAY
BOSTON, MA 02130 US
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Contact VINCENT J MORGAN
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 05/20/2003
Decision Date 11/23/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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