FDA 510(k) Application Details - K081579

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K081579
Device Name Implant, Endosseous, Root-Form
Applicant INVENTUS CO., LTD
4 INNOVATION DR.
DUNDAS, ONTARIO L9H 7P3 CA
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Contact ROSHANA AHMED
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 06/05/2008
Decision Date 09/17/2008
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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