FDA 510(k) Application Details - K013802

Device Classification Name Post, Root Canal

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510(K) Number K013802
Device Name Post, Root Canal
Applicant IVOCLAR VIVADENT, INC.
175 PINEVIEW DR.
AMHERST, NY 14228 US
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Contact DONNA M HARTNETT
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Regulation Number 872.3810

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Classification Product Code ELR
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Date Received 11/15/2001
Decision Date 05/01/2002
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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