FDA 510(k) Application Details - K152845

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K152845
Device Name Abutment, Implant, Dental, Endosseous
Applicant ALLIED DENTAL SOLUTIONS
1170 CENTRE DR #1
CITY OF INDUSTRY, CA 91789 US
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Contact Peter Zhou
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 09/29/2015
Decision Date 03/14/2016
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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