FDA 510(k) Application Details - K152936

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K152936
Device Name Activator, Ultraviolet, For Polymerization
Applicant NATIONAL DENTAL INC.
3-149 COLLIER ST.
BARRIE L4M 1H6 CA
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Contact EDWIN FIRST
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 10/05/2015
Decision Date 11/13/2015
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 Y
Expedited Review



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