FDA 510(k) Application Details - K963922

Device Classification Name Resin, Root Canal Filling

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510(K) Number K963922
Device Name Resin, Root Canal Filling
Applicant WALLACE A. ERICKSON & CO.
1920 NORTH CLYBOURN AVE.
CHICAGO, IL 60614 US
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Contact ABNER T DE LA CRUZ
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Regulation Number 872.3820

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Classification Product Code KIF
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Date Received 09/30/1996
Decision Date 12/06/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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