FDA 510(k) Application Details - K152555

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K152555
Device Name Implant, Endosseous, Root-Form
Applicant AriaBio International Inc
229 Overland Ave, Suite 118
Los Angeles, CA 90064 US
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Contact Hagai Jacobsen
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 09/08/2015
Decision Date 02/11/2016
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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