FDA 510(k) Application Details - K092507

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K092507
Device Name Implant, Endosseous, Root-Form
Applicant ZITERION
BAHNHOFSTRASSE 3
UFFENHEIM 97215 DE
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Contact STEFFEN KAHDEMANN
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 08/17/2009
Decision Date 05/11/2010
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

FDA Source Information for K092507


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