FDA 510(k) Application Details - K073645

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K073645
Device Name Implant, Endosseous, Root-Form
Applicant 659543 BC LTD.
#404, 1023 WOLFE AVE
VANCOUVER, BC V6H 1V6 CA
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Contact HAROLD BERGMAN
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 12/26/2007
Decision Date 10/21/2008
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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