FDA 510(k) Application Details - K091182

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K091182
Device Name Implant, Endosseous, Root-Form
Applicant CHAMPIONS IMPLANTS GMBH
JAHNSTRASSE 14
TUNINGEN, BADEN-WUERTTEMBERG 78609 DE
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Contact MARCUS WEINACKER
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 04/23/2009
Decision Date 01/07/2010
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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