FDA 510(k) Application Details - K090709

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K090709
Device Name Implant, Endosseous, Root-Form
Applicant CORTEX DENTAL IMPLANTS INDUSTRIES, LTD
INDUSTRIAL PARK 13
MIZPE AVIV, M.P. MISGAV 20187 IL
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Contact BENNY AZARY
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 03/18/2009
Decision Date 07/07/2009
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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